[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2005 Edition]
[From the U.S. Government Printing Office]
[[Page i]]
21
Parts 500 to 599
Revised as of April 1, 2005
Food and Drugs
________________________
Containing a codification of documents of general
applicability and future effect
As of April 1, 2005
With Ancillaries
Published by
Office of the Federal Register
National Archives and Records
Administration
A Special Edition of the Federal Register
[[Page ii]]
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[[Page iii]]
Table of Contents
Page
Explanation................................................. v
Title 21:
Chapter I--Food and Drug Administration, Department
of Health and Human Services (Continued) 3
Finding Aids:
Material Approved for Incorporation by Reference........ 555
Table of CFR Titles and Chapters........................ 557
Alphabetical List of Agencies Appearing in the CFR...... 575
List of CFR Sections Affected........................... 585
[[Page iv]]
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Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 21 CFR 500.23 refers
to title 21, part 500,
section 23.
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[[Page v]]
EXPLANATION
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
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name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
The appropriate revision date is printed on the cover of each
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LEGAL STATUS
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HOW TO USE THE CODE OF FEDERAL REGULATIONS
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OMB CONTROL NUMBERS
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collection request.
[[Page vi]]
Many agencies have begun publishing numerous OMB control numbers as
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OBSOLETE PROVISIONS
Provisions that become obsolete before the revision date stated on
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(a) The incorporation will substantially reduce the volume of
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(b) The matter incorporated is in fact available to the extent
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(c) The incorporating document is drafted and submitted for
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Properly approved incorporations by reference in this volume are
listed in the Finding Aids at the end of this volume.
What if the material incorporated by reference cannot be found? If
you have any problem locating or obtaining a copy of material listed in
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the revision dates of the 50 CFR titles.
[[Page vii]]
REPUBLICATION OF MATERIAL
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Office of the Federal Register.
April 1, 2005.
[[Page ix]]
THIS TITLE
Title 21--Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The
first eight volumes, containing parts 1-1299, comprise Chapter I--Food
and Drug Administration, Department of Health and Human Services. The
ninth volume, containing part 1300 to end, includes Chapter II--Drug
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes
represent all current regulations codified under this title of the CFR
as of April 1, 2005.
For this volume, Ruth Green was Chief Editor. The Code of Federal
Regulations publication program is under the direction of Frances D.
McDonald, assisted by Alomha S. Morris.
[[Page 1]]
TITLE 21--FOOD AND DRUGS
(This book contains parts 500 to 599)
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Part
chapter i--Food and Drug Administration, Department of
Health and Human Services (Continued)..................... 500
[[Page 3]]
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
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Editorial Note: Nomenclature changes to chapter I appear at 69 FR
13717, Mar. 24, 2004, and 69 FR 18803, Apr. 9, 2004.
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
Part Page
500 General..................................... 5
501 Animal food labeling........................ 15
502 Common or usual names for nonstandardized
animal foods............................ 32
509 Unavoidable contaminants in animal food and
food-packaging material................. 33
510 New animal drugs............................ 37
511 New animal drugs for investigational use.... 49
514 New animal drug applications................ 54
515 Medicated feed mill license................. 87
520 Oral dosage form new animal drugs........... 92
522 Implantation or injectable dosage form new
animal drugs............................ 218
524 Ophthalmic and topical dosage form new
animal drugs............................ 300
526 Intramammary dosage forms................... 327
529 Certain other dosage form new animal drugs.. 333
530 Extralabel drug use in animals.............. 340
556 Tolerances for residues of new animal drugs
in food................................. 346
558 New animal drugs for use in animal feeds.... 363
564 [Reserved]
570 Food additives.............................. 491
571 Food additive petitions..................... 499
573 Food additives permitted in feed and
drinking water of animals............... 504
579 Irradiation in the production, processing,
and handling of animal feed and pet food 522
582 Substances generally recognized as safe..... 523
[[Page 4]]
584 Food substances affirmed as generally
recognized as safe in feed and drinking
water of animals........................ 548
589 Substances prohibited from use in animal
food or feed............................ 548
590-599 [Reserved]
[[Page 5]]
SUBCHAPTER E_ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 500_GENERAL--Table of Contents
Subpart A [Reserved]
Subpart B_Specific Administrative Rulings and Decisions
Sec.
500.23 Thermally processed low-acid foods packaged in hermetically
sealed containers.
500.24 Emergency permit control.
500.25 Anthelmintic drugs for use in animals.
500.26 Timed-release dosage form drugs.
500.27 Methylene blue-containing drugs for use in animals.
500.29 Gentian violet for use in animal feed.
500.30 Gentian violet for animal drug use.
500.35 Animal feeds contaminated with Salmonella microorganisms.
500.45 Use of polychlorinated biphenyls (PCB's) in the production,
handling, and storage of animal feed.
500.46 Hexachlorophene in animal drugs.
500.50 Propylene glycol in or on cat food.
Subpart C_Animal Drug Labeling Requirements
500.51 Labeling of animal drugs; misbranding.
500.52 Use of terms such as ``tonic'', ``tone'', ``toner'', or
``conditioner'' in the labeling of preparations intended for
use in or on animals.
500.55 Exemption from certain drug-labeling requirements.
Subpart D_Requirements for Specific Animal Drugs
500.65 Epinephrine injection 1:1,000 in 10-milliliter containers for
emergency treatment of anaphylactoid shock in cattle, horses,
sheep, and swine.
Subpart E_Regulation of Carcinogenic Compounds Used in Food-Producing
Animals
500.80 Scope of this subpart.
500.82 Definitions.
500.84 Conditions for approval of the sponsored compound.
500.86 Marker residue and target tissue.
500.88 Regulatory method.
500.90 Waiver of requirements.
500.92 Implementation.
Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b,
371.
Source: 40 FR 13802, Mar. 27, 1975, unless otherwise noted.
Subpart A [Reserved]
Subpart B_Specific Administrative Rulings and Decisions
Sec. 500.23 Thermally processed low-acid foods packaged in hermetically
sealed containers.
The provisions of part 113 of this chapter shall apply to the
manufacture, processing or packing of low-acid foods in hermetically
sealed containers, and intended for use as food for animals.
[61 FR 37681, July 19, 1996]
Sec. 500.24 Emergency permit control.
The provisions of part 108 of this chapter shall apply to the
issuance of emergency control permits for the manufacturer or packer of
thermally processed low-acid foods packaged in hermetically sealed
containers, and intended for use as food for animals.
[61 FR 37681, July 19, 1996]
Sec. 500.25 Anthelmintic drugs for use in animals.
(a) The Commissioner of Food and Drugs has determined that, in order
to assure that anthelmintic drugs, including animal feeds bearing or
containing such drugs, which do not carry the prescription statement are
labeled to provide adequate directions for their effective use, labeling
of these anthelmintic drugs shall bear, in addition to other required
information, a statement that a veterinarian should be consulted for
assistance in the diagnosis, treatment, and control of parasitism.
(b) The label and any labeling furnishing or purporting to furnish
directions for use, shall bear conspicuously the following statement:
``Consult your veterinarian for assistance in the diagnosis, treatment,
and control of parasitism.''
[[Page 6]]
(c) For drugs covered by approved new animal drug applications, the
labeling revisions required for compliance with this section may be
placed into effect without prior approval as provided for in Sec. 514.8
(d) and (e) of this chapter. For animal feeds bearing or containing
anthelmintic drugs covered by approved applications, the labeling
revisions required for compliance with this section may be placed into
effect without the submission of supplemental applications as provided
for in Sec. 514.9 of this chapter.
(d) Labeling revisions required for compliance with this section
shall be placed into effect by February 25, 1975, following which, any
such drugs that are introduced into interstate commerce and not in
compliance with this section will be subject to regulatory proceedings.
Sec. 500.26 Timed-release dosage form drugs.
(a) Drugs are being offered in dosage forms that are designed to
release the active ingredients over a prolonged period of time. There is
a possibility of unsafe overdosage or ineffective dosage if such
products are improperly made and the active ingredients are released at
one time, over too short or too long a period of time, or not released
at all. Drugs marketed in this form, which are referred to by such terms
as timed-release, controlled-release, prolonged-release, sustained-
release, or delayed-release drugs, are regarded as new animal drugs
within the meaning of section 201(v) of the Federal Food, Drug, and
Cosmetic Act.
(b) Timed-release dosage form animal drugs that are introduced into
interstate commerce are deemed to be adulterated within the meaning of
section 501(a)(5) of the act and subject to regulatory action unless
such animal drug is the subject of an approved new animal drug
application as required by paragraph (a) of this section.
(c) The fact that the labeling of this kind of drug may claim
delayed, prolonged, controlled, or sustained-release of all or only some
of the active ingredients does not affect the new animal drug status of
such articles. A new animal drug application is required in any such
case.
(d) New animal drug applications for timed-release dosage form
animal drugs must contain, among other things, data to demonstrate
safety and effectiveness by establishing that the article is
manufactured using procedures and controls to ensure release of the
total dosage at a safe and effective rate. Data submitted in the new
animal drug application must demonstrate that the formulation of the
drug and the procedures used in its manufacture will ensure release of
the active ingredient(s) of the drug at a safe and effective rate and
that these release characteristics will be maintained until the
expiration date of the drug. When the drug is intended for use in food-
producing animals, data submitted must also demonstrate that, with
respect to possible residues of the drug, food derived from treated
animals is safe for consumption.
[42 FR 8635, Feb. 11, 1977, as amended at 60 FR 38480, July 27, 1995]
Sec. 500.27 Methylene blue-containing drugs for use in animals.
(a) New information requires a re- evaluation of the status of drugs
containing methylene blue (tetramethylthionine chloride) for oral use in
cats or dogs.
(1)(i) It has been demonstrated that two orally administered urinary
antiseptic-antispasmodic preparations that contained methylene blue
cause Heinz body hemolytic anemia in cats when used according to label
directions. The specific cause of the reaction was determined to be the
methylene blue contained in the preparations. The reaction can be severe
enough to cause death of treated animals.
(ii) The Heinz body hemolytic anemia reaction to methylene blue has
also been demonstrated in dogs under laboratory conditions. The precise
mechanism by which methylene blue produces the characteristic
erythrocytic inclusion bodies (Heinz bodies) and associated hemolytic
anemia is unclear.
(2) The effectiveness of orally administered methylene blue as a
urinary antiseptic is open to question. It appears that following oral
administration, methylene blue is poorly and erratically absorbed and
also slowly and erratically excreted in the urine. Studies
[[Page 7]]
in the dog indicate it is excreted in the urine essentially as
leukomethylene blue stabilized in some manner. Methylene blue itself is
stepwise demethylated in alkaline solutions (alkaline urine being a
frequent consequence of urinary infection) to Azure B, Azure A, and
Azure C. The antiseptic efficacy of all of these excretion products is
unsubstantiated.
(3) In view of the foregoing, the Commissioner has concluded that
animal drugs containing methylene blue for oral use in cats or dogs are
neither safe nor generally recognized as effective within the meaning of
section 201(v) of the act and are therefore considered new animal drugs.
Accordingly, all prior formal and informal opinions expressed by the
Food and Drug Administration that such drugs are ``not new drugs'' or
``no longer new drugs'' are hereby revoked.
(b) Animal drugs that contain methylene blue for oral use in cats or
dogs and not the subject of an approved new animal drug application
(NADA) are deemed to be adulterated under the provisions of section
501(a) (5) and/or (6) and/or misbranded under section 502(a) of the act
and subject to regulatory action as of April 10, 1978.
(c) Sponsors of animal drugs that contain methylene blue for oral
use in cats or dogs and not the subject of an approved new animal drug
application (NADA) may submit an application in conformity with Sec.
514.1 of this chapter. Such applications will be processed in accordance
with section 512 of the act. Submission of an NADA will not constitute
grounds for continued marketing of this drug substance until such
application is approved.
(d) New animal drug applications required by this regulation
pursuant to section 512 of the act shall be submitted to the Food and
Drug Administration. Center for Veterinary Medicine, Office of New
Animal Drug Evaluation (HFV-100), 7500 Standish Pl., Rockville, MD
20855.
[43 FR 9803, Mar. 10, 1978; 43 FR 12310, Mar. 24, 1978, as amended at 54
FR 18279, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992; 60 FR 38480, July
27, 1995]
Sec. 500.29 Gentian violet for use in animal feed.
The Food and Drug Administration has determined that gentian violet
is not generally recognized as safe for use in animal feed and is a food
additive subject to section 409 of the Federal Food, Drug, and Cosmetic
Act (the act), unless it is intended for use as a new animal drug, in
which case it is subject to section 512 of the act. The Food and Drug
Administration has determined that gentian violet is not prior
sanctioned for any use in animal feed.
[56 FR 40506, Aug. 15, 1991]
Sec. 500.30 Gentian violet for animal drug use.
The Food and Drug Administration (FDA) has determined that gentian
violet is not generally recognized as safe and effective for any
veterinary drug use in food animals and is a new animal drug subject to
section 512 of the Federal Food, Drug, and Cosmetic Act. FDA has
determined that gentian violet is not exempted from new animal drug
status under the ``grandfather'' provisions of the Drug Amendments of
1962 (21 U.S.C. 342).
[56 FR 40507, Aug. 15, 1991]
Sec. 500.35 Animal feeds contaminated with Salmonella microorganisms.
(a) Investigations by the Food and Drug Administration, the Centers
for Disease Control of the U.S. Public Health Service, the Animal Health
Division of the Agricultural Research Service, U.S. Department of
Agriculture, and by various State public health agencies have revealed
that processed fish meal, poultry meal, meat meal, tankage, and other
animal byproducts intended for use in animal feed may be contaminated
with Salmonella bacteria, an organism pathogenic to man and animals.
Contamination of these products may occur through inadequate heat
treatment of the product during its processing or through
recontamination of the heat-treated product during a time of improper
storage or handling subsequent to processing.
(b) Articles used in food for animals are included within the
definition of
[[Page 8]]
food in section 201(f) of the Federal Food, Drug, and Cosmetic Act.
Further, Salmonella contamination of such animal feeds having the
potentiality for producing infection and disease in animals must be
regarded as an adulterant within the meaning of section 402(a) of the
act. Therefore, the Food and Drug Administration will regard as
adulterated within the meaning of section 402(a) of the act shipments of
the following when intended for animal feed and encountered in
interstate commerce and found upon examination to be contaminated with
Salmonella microorganisms: Bone meal, blood meal, crab meal, feather
meal, fish meal, fish solubles, meat scraps, poultry meat meal, tankage,
or other similar animal byproducts, or blended mixtures of these.
[40 FR 13802, Mar. 27, 1975, as amended at 54 FR 18279, Apr. 28, 1989]
Sec. 500.45 Use of polychlorinated biphenyls (PCB's) in the production,
handling, and storage of animal feed.
(a) Polychlorinated biphenyls (PCB's) represent a class of toxic
industrial chemicals manufactured and sold under a variety of trade
names, including: Aroclor (United States); Phenoclor (France); Colphen
(Germany); and Kanaclor (Japan). PCB's are highly stable, heat
resistant, and nonflammable chemicals. Industrial uses of PCB's include,
or did include in the past, their use as electrical transformer and
capacitor fluids, heat transfer fluids, hydraulic fluids, plasticizers,
and in formulations of lubricants, coatings, and inks. Their unique
physical and chemical properties and widespread, uncontrolled industrial
applications have caused PCB's to be a persistent and ubiquitous
contaminant in the environment, causing the contamination of certain
foods. In addition, incidents have occurred in which PCB's have directly
contaminated animal feeds as a result of industrial accidents (leakage
or spillage of PCB fluids from plant equipment). These accidents in turn
cause the contamination of food intended for human consumption (meat,
milk, and eggs). Investigations by the Food and Drug Administration have
revealed that heat exchange fluids for certain pasteurization equipment
used in processing animal feed contain PCB's. Although heat exchange
fluids in such equipment are considered to be in closed systems, leakage
has occurred that resulted in direct contamination of animal feed with
PCB's and subsequently resulted in the transfer of PCB's to human food
produced by animals consuming the contaminated feed. The use of PCB-
containing coatings on the inner walls of silos has resulted in the
contamination of silage which has in turn caused PCB residues in the
milk of dairy cows consuming the contaminated silage. Since PCB's are
toxic chemicals, the PCB contamination of food as a result of these and
other incidents represent a hazard to public health. It is therefore
necessary to place certain restrictions on the industrial uses of PCB's
in the production, handling, and storage of animal feed.
(b) The following special provisions are necessary to preclude
accidental PCB contamination of animal feed:
(1) Coatings or paints for use on the contact surfaces of feed
storage areas may not contain PCB's or any other harmful or deleterious
substances likely to contaminate feed.
(2) New equipment or machinery for handling or processing feed in or
around an establishment producing animal feed shall not contain PCB's.
(3) On or before Sept. 4, 1973, the management of establishments
producing animal feed shall:
(i) Have the heat exchange fluid used in existing equipment or
machinery for handling and processing feed sampled and tested to
determine whether it contains PCB's, or verify the absence of PCB's in
such formulations by other appropriate means. On or before Sept. 4,
1973, any such fluid formulated with PCB's must to the fullest extent
possible commensurate with current good manufacturing practices, be
replaced with a heat exchange fluid that does not contain PCB's.
(ii) Eliminate to the fullest extent possible commensurate with
current good manufacturing practices from the animal feed producing
establishment any PCB-containing lubricants for equipment or machinery
used for handling or processing animal feed.
[[Page 9]]
(iii) Eliminate to the fullest extent possible commensurate with
current good manufacturing practices from the animal feed producing
establishment any other PCB-containing materials, whenever there is a
reasonable expectation that such materials could cause animal feed to
become contaminated with PCB's either as a result of normal use or as a
result of accident, breakage, or other mishap.
(iv) The toxicity and other characteristics of fluids selected as
PCB replacements must be adequately determined so that the least
potentially hazardous replacement should be used. In making this
determination with respect to a given fluid, consideration should be
given to (a) its toxicity; (b) the maximum quantity that could be
spilled onto a given quantity of food before it would be noticed, taking
into account its color and odor; (c) possible signaling devices in the
equipment to indicate a loss of fluid, etc.; (d) and its environmental
stability and tendency to survive and be concentrated through the food
chain. The judgment as to whether a replacement fluid is sufficiently
non-hazardous is to be made on an individual installation and operation
basis.
(c) For the purpose of this section, the provisions do not apply to
electrical transformers and condensers containing PCB's in sealed
containers.
(d) For the purpose of this section, the term animal feed includes
all articles used for food or drink for animals other than man.
Sec. 500.46 Hexachlorophene in animal drugs.
(a) The Commissioner of Food and Drugs has determined that there are
no adequate data to establish that animal drugs containing
hexachlorophene are safe and effective for any animal use other than in
topical products for use on non-food-producing animals as part of a
product preservative system at a level not to exceed 0.1 percent; that
there is no information on the potential risk to humans from exposure to
hexachlorophene by persons who apply animal products containing the drug
at levels higher than 0.1 percent; and that there is likewise no
information on human exposure to animals on which these animal drugs
have been used and no information on possible residues of
hexachlorophene in edible products of food-producing animals treated
with new animal drugs that contain any quantity of hexachlorophene.
(b) Animal drugs containing hexachlorophene for other than
preservative use on non-food-producing animals at levels not exceeding
0.1 percent are considered new animal drugs and shall be the subject of
new animal drug applications (NADA's).
(c) Any person currently marketing animal drugs that contain
hexachlorophene other than as part of a product preservative system for
products used on non-food-producing animals at a level not exceeding 0.1
percent shall submit a new animal drug application, supplement an
existing application, or reformulate the product by September 29, 1977.
Each application or supplemental application shall include adequate data
to establish that the animal drug is safe and effective. If the animal
drug is currently subject to an approved new animal drug application,
each reformulation shall require an approved supplemental application.
The interim marketing of these animal drugs may continue until the
application has been approved, until it has been determined that the
application is not approvable under the provisions of Sec. 514.111 of
this chapter, or until an existing approved application has been
withdrawn.
(d) After September 29, 1977, animal drugs that contain
hexachlorophene other than for preservative use on non-food-producing
animals at a level not exceeding 0.1 percent that are introduced into
interstate commerce shall be deemed to be adulterated within the meaning
of section 501(a)(5) of the act (21 U.S.C. 351(a)(5)) unless such animal
drug is the subject of a new animal drug application submitted pursuant
to paragraph (c) of this section. Action to withdraw approval of new
animal drug applications will be initiated if supplemental new animal
drug applications have not been submitted in accordance with this
section.
(e) New animal drug applications submitted for animal drugs
containing hexachlorophene for use in or on food-
[[Page 10]]
producing animals shall include adequate data to assure that edible
products from treated animals are safe for human consumption under the
labeled conditions of use.
[42 FR 33725, July 1, 1977; 42 FR 37975, July 26, 1977]
Sec. 500.50 Propylene glycol in or on cat food.
The Food and Drug Administration has determined that propylene
glycol in or on cat food is not generally recognized as safe and is a
food additive subject to section 409 of the Federal Food, Drug, and
Cosmetic Act (the act). The Food and Drug Administration also has
determined that this use of propylene glycol is not prior sanctioned.
[61 FR 19544, May 2, 1996]
Subpart C_Animal Drug Labeling Requirements
Sec. 500.51 Labeling of animal drugs; misbranding.
(a) Among the representations on the label or labeling of an animal
drug which will render the drug misbranded are any broad statements
suggesting or implying that the drug is not safe and effective for use
when used in accordance with labeling direction, or suggesting or
implying that the labeling does not contain adequate warnings or
adequate directions for use. Such statements include, but are not
limited to:
(1) Any statement that disclaims liability when the drug is used in
accordance with directions for use contained on the label or labeling.
(2) Any statement that disclaims liability when the drug is used
under ``abnormal'' or ``unforeseeable'' conditions.
(3) Any statement limiting the warranty for the products to a
warranty that the drug in the package contains the ingredients listed on
the label.
(b) This regulation is not intended to prohibit any liability
disclaimer that purports to limit the amount of damages or that sets
forth the legal theory under which damages are to be recovered.
(c) Any person wishing to obtain an evaluation of an animal drug
liability disclaimer under this regulation may submit it to Division of
Compliance, (HFV-230), Center for Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl., Rockville, MD 20855. A supplemental
NADA providing appropriately revised labeling shall be submitted for any
approved new animal drug the labeling of which is not in compliance with
this regulation.
[41 FR 8473, Feb. 27, 1976, as amended at 54 FR 18279, Apr. 28, 1989; 57
FR 6475, Feb. 25, 1992]
Sec. 500.52 Use of terms such as ``tonic'', ``tone'', ``toner'', or
``conditioner'' in the labeling of preparations intended for use in
or on animals.
(a) The use of terms such as tonic, tone, toner, and similar terms
in the labeling of a product intended for use in or on animals implies
that such product is capable of a therapeutic effect(s) and causes such
a product to be a drug within the meaning of section 201(g) of the
Federal Food, Drug, and Cosmetic Act. The unqualified use of such terms
in a product's labeling fails to provide adequate directions and
indications for use of such product and causes it to be misbranded
within the meaning of section 502(a) and (f)(1) of the act. The terms
tonic, tone, toner, and similar terms may be used in labeling only when
appropriately qualified so as to fully inform the user regarding the
intended use(s) of the product.
(b) The unqualified use of the term conditioner and similar terms in
the labeling of a product intended for use in or on animals implies that
such product is capable of a therapeutic effect(s) and causes such a
product to be a drug within the meaning of section 201(g) of the act.
The unqualified use of such terms in a product's labeling fails to
provide adequate directions and indications for use of such product and
causes it to be misbranded within the meaning of section 502(a) and
(f)(1) of the act. The term conditioner and similar terms may be used in
labeling only when appropriately qualified so as to fully inform the
user regarding the intended use(s) of the product. A product labeled as
a ``conditioner'' or with a similar term can be either a food or drug
depending upon the manner in
[[Page 11]]
which the term is qualified in the labeling to reflect the product's
intended use.
(c) An article so qualified as to be represented as a drug must be
the subject of an approved new animal drug application unless the use of
the article under the conditions set forth in its labeling is generally
recognized as safe and effective among experts qualified by scientific
training and experience to evaluate the safety and effectiveness of
animal drugs.
Sec. 500.55 Exemption from certain drug-labeling requirements.
(a) Section 201.105(c) of this chapter provides that in the case of
certain drugs for which directions, hazards, warnings, and use
information are commonly known to practitioners licensed by law, such
information may be omitted from the dispensing package. Under this
proviso, the Commissioner of Food and Drugs will offer an opinion, upon
written request, stating reasonable grounds therefore on a proposal to
omit such information from the dispensing package.
(b) The Commissioner of Food and Drugs has considered submitted
material covering a number of drug products and has offered the opinion
that the following drugs when intended for those veterinary uses for
which they are now generally employed by the veterinary medical
profession, should be exempt from the requirements of Sec. 201.105(c)
of this chapter, provided that they meet the conditions prescribed in
this paragraph. Preparations that are not in dosage unit form (for
example, solutions) will be regarded as meeting the conditions with
respect to the maximum quantity of drug per dosage unit if they are
prepared in a manner that enables accurate and ready administration of a
quantity of drug not in excess of the stated maximum per dosage unit:
Atropine sulfate. As an injectable for cattle, goats, horses, pigs, and
sheep, not in excess of 15 milligrams per dosage unit; as an injectable
for cats and dogs, not in excess of 0.6 milligram per dosage unit.
Barbital sodium. For oral use in cats and dogs, not in excess of 300
milligrams per dosage unit.
Epinephrine injection. 1:1,000. For cats, dogs, cattle, goats, horses,
pigs, and sheep (except as provided in Sec. 500.65).
Morphine sulfate. As an injectable for dogs, not in excess of 15
milligrams per dosage unit.
Pentobarbital sodium. For oral use in cats and dogs, not in excess of
100 milligrams per dosage unit.
Phenobarbital sodium. For oral use in cats and dogs, not in excess of
100 milligrams per dosage unit.
Procaine hydrochloride injection. Containing not in excess of 2 percent
procaine hydrochloride, with or without epinephrine up to a
concentration of 1:50,000. For use in cats, dogs, cattle, goats, horses,
pigs, and sheep.
Thyroid. For oral use in dogs, not in excess of 60 milligrams per dosage
unit.
Subpart D_Requirements for Specific Animal Drugs
Sec. 500.65 Epinephrine injection 1:1,000 in 10-milliliter containers
for emergency treatment of anaphylactoid shock in cattle, horses,
sheep, and swine.
(a) Anaphylactoid reactions in cattle, horses, sheep, and swine
occur occasionally from the injection of antibiotics, bacterins, and
vaccines. Adequate directions for use of these antibiotics, bacterins,
and vaccines can generally be written for use by the laity and thus are
available to livestock producers. Epinephrine injection is effective for
the treatment of anaphylactoid reactions in animals and would be of
value in saving lives of animals if it were readily available at the
time of administration of the causative agents. In connection with this
problem the Food and Drug Administration has obtained the views of the
Advisory Committee on Veterinary Medicine, and other experts, and has
concluded that adequate directions for over-the-counter sale of
epinephrine injection 1:1,000 can be prepared.
(b) In view of the above, the Commissioner of Food and Drugs has
concluded that it is in the public interest to make epinephrine
injection 1:1,000 available for sale without a prescription provided
that it is packaged in vials not exceeding 10 milliliters and its label
bears, in addition to other required information, the following
statements in a prominent and conspicuous manner: ``For emergency use
only in treating
[[Page 12]]
anaphylactoid shock. Usual Dosage: Cattle, horses, sheep, and swine--1
cubic centimeter per 100 pounds of body weight. Inject subcutaneously''.
(c) The labeling must also bear a description of the symptoms of
anaphylactoid shock including glassy eyes, increased salivation,
grinding of the teeth, rapid breathing, muscular tremors, staggering
gait, and collapse with death following. These symptoms may appear
shortly after injection of a bacterin, vaccine, or antibiotic.
Subpart E_Regulation of Carcinogenic Compounds Used in Food-Producing
Animals
Source: 52 FR 49586, Dec. 31, 1987, unless otherwise noted.
Sec. 500.80 Scope of this subpart.
(a) The Federal Food, Drug, and Cosmetic Act requires that sponsored
compounds intended for use in food-producing animals be shown to be safe
and that food produced from animals exposed to these compounds be shown
to be safe for consumption by people. The statute prohibits the use in
food-producing animals of any compound found to induce cancer when
ingested by people or animals unless it can be determined by methods of
examination prescribed or approved by the Secretary (a function
delegated to the Commissioner of Food and Drugs) that no residue of that
compound will be found in the food produced from those animals under
conditions of use reasonably certain to be followed in practice. This
subpart identifies the steps a sponsor of a compound shall follow to
secure the approval of the compound. FDA guidance documents contain the
procedures and protocols FDA recommends for the implementation of this
subpart. These guidance documents are available from the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Requests for these guidance
documents should be identified with Docket No. 1983D-0288.
(b) If FDA concludes on the basis of the threshold assessment that a
sponsor shall conduct carcinogenicity testing on the sponsored compound,
FDA will also determine whether and to what extent the sponsor shall
conduct carcinogenicity testing on metabolites of the sponsored
compound. The bioassays that a sponsor conducts must be designed to
assess carcinogenicity and to determine the quantitative aspects of any
carcinogenic response.
(c) If FDA concludes on the basis of the threshold assessment or at
a later time during the approval process that the data show that the
sponsored compound and its metabolites should not be subject to this
subpart, FDA will continue to consider the compound for approval under
the general safety provisions of the act for risks other than cancer.
(d) This subpart does not apply to essential nutrients.
[52 FR 49586, Dec. 31, 1987, as amended at 59 FR 14365, Mar. 28, 1994;
62 FR 66983, Dec. 23, 1997; 65 FR 56480, Sept. 19, 2000; 67 FR 78174,
Dec. 23, 2002; 68 FR 24879, May 9, 2003; 69 FR 17292, Apr. 2, 2004]
Sec. 500.82 Definitions.
(a) The definitions and interpretations contained in section 201 of
the act apply to those terms when used in this subpart.
(b) The following definitions apply to this subpart:
Act means the Federal Food, Drug, and Cosmetic Act (sections 201-
901, 52 Stat. 1040 et seq. as amended (21 U.S.C. 301-392)).
Essential nutrients means compounds that are found in the tissues of
untreated, healthy target animals and not produced in sufficient
quantity to support the animal's growth, development, function, or
reproduction, e.g., vitamins, essential minerals, essential amino acids,
and essential fatty acids. These compounds must be supplied from
external sources.
FDA means the Food and Drug Administration.
Limit of detection (LOD) means the lowest concentration of analyte
that can be confirmed by the approved regulatory method.
Marker residue means the residue selected for assay whose
concentration is in a known relationship to the concentration of the
residue of carcinogenic concern in the last tissue to deplete to its
Sm.
[[Page 13]]
Preslaughter withdrawal period or milk discard time means the time
after cessation of administration of the sponsored compound at which no
residue is detectable in the edible product using the approved
regulatory method (i.e., the marker residue is below the LOD).
Regulatory method means the aggregate of all experimental procedures
for measuring and confirming the presence of the marker residue of the
sponsored compound in the target tissue of the target animal.
Rm means the concentration of the marker residue in the
target tissue when the residue of carcinogenic concern is equal to
Sm.
Residue means any compound present in edible tissues of the target
animal which results from the use of the sponsored compound, including
the sponsored compound, its metabolites, and any other substances formed
in or on food because of the sponsored compound's use.
Residue of carcinogenic concern means all compounds in the total
residue of a demonstrated carcinogen excluding any compounds judged by
FDA not to present a carcinogenic risk.
Sm means the concentration of residue in a specific
edible tissue corresponding to a maximum lifetime risk of cancer in the
test animals of 1 in 1 million.
So means the concentration of the test compound in the
total diet of test animals that corresponds to a maximum lifetime risk
of cancer in the test animals of 1 in 1 million. For the purpose of this
subpart, FDA will also assume that this So will correspond to
the concentration of residue of carcinogenic concern in the total human
diet that represents no significant increase in the risk of cancer to
people.
Sponsor means the person or organization proposing or holding an
approval by FDA for the use of a sponsored compound.
Sponsored compound means any drug or food additive or color additive
proposed for use, or used, in food-producing animals or in their feed.
Target animals means the production class of animals in which a
sponsored compound is proposed or intended for use.
Target tissue means the edible tissue selected to monitor for
residues in the target animals, including, where appropriate, milk or
eggs.
Test animals means the species selected for use in the toxicity
tests.
Threshold assessment means FDA's review of data and information
about a sponsored compound to determine whether chronic bioassays in
test animals are necessary to resolve questions concerning the
carcinogenicity of the compound.
[52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002]
Sec. 500.84 Conditions for approval of the sponsored compound.
(a) On the basis of the results of the chronic bioassays and other
information, FDA will determine whether any of the substances tested are
carcinogenic.
(b) If FDA concludes that the results of the bioassays do not
establish carcinogenicity, then FDA will not subject the sponsored
compound to the remainder of the requirements of this subpart.
(c) For each sponsored compound that FDA decides should be regulated
as a carcinogen, FDA will analyze the data from the bioassays using a
statistical extrapolation procedure.
(1) For each substance tested in separate bioassays, FDA will
calculate the concentration of the residue of carcinogenic concern that
corresponds to a maximum lifetime risk to the test animal of 1 in 1
million. FDA will designate the lowest value obtained as So.
Because the total diet is not derived from food-producing animals, FDA
will make corrections for food intake. FDA will designate as
Sm the concentration of residue in a specific edible tissue
corresponding to a maximum lifetime risk of cancer in test animals of 1
in 1 million.
(2) From the appropriate residue chemistry data FDA will calculate
the Rm as described in Sec. 500.86(c). The sponsor must
provide a regulatory method in accordance with Sec. 500.88(b). FDA will
calculate the LOD of the method from data submitted by the sponsor under
Sec. 500.88. The LOD must be less than or equal to Rm.
[[Page 14]]
(3) FDA will conclude that the provisions of this subpart are
satisfied when no residue of the compound is detectable (that is, the
marker residue is below the LOD) using the approved regulatory method
under the conditions of use of the sponsored compound, including any
required preslaughter withdrawal period or milk discard time.
[52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002]
Sec. 500.86 Marker residue and target tissue.
(a) For each edible tissue, the sponsor shall measure the depletion
of the residue of carcinogenic concern until its concentration is at or
below Sm.
(b) In one or more edible tissues, the sponsor shall also measure
the depletion of one or more potential marker residues until the
concentration of the residue of carcinogenic concern is at or below
Sm.
(c) From these data, FDA will select a target tissue and a marker
residue and designate the concentration of marker residue
(Rm) that the regulatory method must be capable of measuring
in the target tissue. FDA will select Rm such that the
absence of the marker residue in the target tissue above Rm
can be taken as confirmation that the residue of carcinogenic concern
does not exceed Sm in each of the edible tissues and,
therefore, that the residue of carcinogenic concern in the diet of
people does not exceed So.
(d) When a compound is to be used in milk- or egg-producing animals,
milk or eggs must be the target tissue in addition to the tissue
selected to monitor for residues in the edible carcass.
(Approved by the Office of Management and Budget under control number
0910-0228)
Sec. 500.88 Regulatory method.
(a) The sponsor shall submit for evaluation and validation a
regulatory method developed to monitor compliance with FDA's operational
definition of no residue.
(b) The regulatory method must be able to confirm the identity of
the marker residue in the target tissue at a minimum concentration
corresponding to the Rm. FDA will determine the LOD from the
submitted analytical method validation data.
(c) FDA will publish in the Federal Register the complete regulatory
method for ascertaining the marker residue in the target tissue in
accordance with the provisions of sections 409(c)(3)(A), 512(d)(1)(I),
and 721(b)(5)(B) of the act.
(Approved by the Office of Management and Budget under control number
0910-0228)
[52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002]
Sec. 500.90 Waiver of requirements.
In response to a petition or on the Commissioner's own initiative,
the Commissioner may waive, in whole or in part, the requirements of
this subpart except those provided under Sec. 500.88. A petition for
this waiver may be filed by any person who would be adversely affected
by the application of the requirements to a particular compound. The
petition shall explain and document why the requirements from which a
waiver is requested are not reasonably applicable to the compound, and
set forth clearly the reasons why the alternative procedures will
provide the basis for concluding that approval of the compound satisfies
the requirements of the anticancer provisions of the act. If the
Commissioner determines that waiver of any of the requirements of this
subpart is appropriate, the Commissioner will state the basis for that
determination in the regulation approving marketing of the sponsored
compound.
(Approved by the Office of Management and Budget under control number
0910-0228)
Sec. 500.92 Implementation.
(a) This subpart E applies to all new animal drug applications, food
additive petitions, and color additive petitions concerning any compound
intended for use in food-producing animals (including supplemental
applications and amendments to petitions).
(b) This subpart E also applies in the following manner to compounds
already approved:
(1) For those compounds that FDA determines may induce cancer when
ingested by man or animals, i.e., suspect
[[Page 15]]
carcinogens, Sec. Sec. 500.80(b), 500.82, and 500.90 apply.
(2) For those compounds that FDA determines have been shown to
induce cancer when ingested by man or animals, Sec. Sec. 500.82 through
500.90 apply.
PART 501_ANIMAL FOOD LABELING--Table of Contents
Subpart A_General Provisions
Sec.
501.1 Principal display panel of package form animal food.
501.2 Information panel of package for animal food.
501.3 Identity labeling of animal food in package form.
501.4 Animal food; designation of ingredients.
501.5 Animal food; name and place of business of manufacturer, packer,
or distributor.
501.8 Labeling of animal food with number of servings.
501.15 Animal food; prominence of required statements.
501.17 Animal food labeling warning statements.
501.18 Misbranding of animal food.
Subpart B_Specific Animal Food Labeling Requirements
501.22 Animal foods; labeling of spices, flavorings, colorings, and
chemical preservatives.
Subparts C-E [Reserved]
Subpart F_Exemptions From Animal Food Labeling Requirements
501.100 Animal food; exemptions from labeling.
501.103 Petitions requesting exemptions from or special requirements for
label declaration of ingredients.
501.105 Declaration of net quantity of contents when exempt.
501.110 Animal feed labeling; collective names for feed ingredients.
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343,
348, 371.
Source: 41 FR 38619, Sept. 10, 1976, unless otherwise noted.
Subpart A_General Provisions
Sec. 501.1 Principal display panel of package form animal food.
The term principal display panel as it applies to food in package
form and as used in this part, means the part of a label that is most
likely to be displayed, presented, shown, or examined under customary
conditions of display for retail sale. The principal display panel shall
be large enough to accommodate all the mandatory label information
required to be placed thereon by this part with clarity and
conspicuousness and without obscuring design, vignettes, or crowding.
Where packages bear alternate principal display panels, information
required to be placed on the principal display panel shall be duplicated
on each principal display panel. For the purpose of obtaining uniform
type size in declaring the quantity of contents for all packages of
substantially the same size, the term area of the principal display
panel means the area of the side or surface that bears the principal
display panel, which area shall be:
(a) In the case of a rectangular package where one entire side
properly can be considered to be the principal display panel side, the
product of the height times the width of that side;
(b) In the case of a cylindrical or nearly cylindrical container, 40
percent of the product of the height of the container times the
circumference;
(c) In the case of any otherwise shaped container, 40 percent of the
total surface of the container: Provided, however, That where such
container presents an obvious principal display panel such as the top of
a triangular or circular package, the area shall consist of the entire
top surface. In determining the area of the principal display panel,
exclude tops, bottoms, flanges at tops and bottoms of cans, and
shoulders and necks of bottles or jars. In the case of cylindrical or
nearly cylindrical containers, information required by this part to
appear on the principal display panel shall appear within that 40
percent of the circumference which is most likely to be displayed,
presented, shown, or examined under customary conditions of display for
retail sale.
[[Page 16]]
Sec. 501.2 Information panel of package for animal food.
(a) The term information panel as it applies to packaged food means
that part of the label immediately contiguous and to the right of the
principal display panel as observed by an individual facing the
principal display panel with the following exceptions:
(1) If the part of the label immediately contiguous and to the right
of the principal display panel is too small to accommodate the necessary
information or is otherwise unusable label space, e.g., folded flaps or
can ends, the panel immediately contiguous and to the right of this part
of the label may be used.
(2) If the package has one or more alternate principal display
panels, the information panel is immediately contiguous and to the right
of any principal display panel.
(3) If the top of the container is the principal display panel and
the package has no alternate principal display panel, the information
panel is any panel adjacent to the principal display panel.
(b) All information required to appear on the label of any package
of food pursuant to Sec. Sec. 501.4, 501.5, 501.8 and 501.17 shall
appear either on the principal display panel or on the information
panel, unless otherwise specified by regulations in this chapter.
(c) All information appearing on the principal display panel or the
information panel pursuant to this section shall appear prominently and
conspicuously, but in no case may the letters and/or numbers be less
than \1/16\ inch in height unless an exemption pursuant to paragraph (f)
of this section is established. The requirements for conspicuousness and
legibility shall include the specifications of Sec. Sec. 501.15 and
501.105(h) (1) and (2).
(1) Packaged foods are exempt from the type size requirements of
this paragraph: Provided, That:
(i) The package is designed such that it has a surface area that can
bear an information panel and/or an alternate principal display panel.
(ii) The area of surface available for labeling on the principal
display panel of the package as this term is defined in Sec. 501.1 is
less than 10 square inches.
(iii) The label information includes a full list of ingredients in
accordance with regulations in this part.
(iv) The information required by paragraph (b) of this section
appears on the principal display panel or information panel label in
accordance with the provisions of this paragraph (c) except that the
type size is not less than \3/64\ inch in height.
(2) Packaged foods are exempt from the type size requirements of
this paragraph: Provided, That:
(i) The package is designed such that it has a single obvious
principal display panel as this term is defined in Sec. 501.1 and has
no other available surface area for an information panel or alternate
principal display panel.
(ii) The area of surface available for labeling on the principal
display panel of the package as this term is defined in Sec. 501.1 is
less than 12 square inches and bears all labeling appearing on the
package.
(iii) The label information includes a full list of ingredients in
accordance with regulations in this part.
(iv) The information required by paragraph (b) of this section
appears on the single, obvious principal display panel in accordance
with the provisions of this paragraph (c) except that the type size is
not less than \1/32\ inch in height.
(3) Packaged foods are exempt from the type size requirements of
this paragraph: Provided, That:
(i) The package is designed such that it has a total surface area
available to bear labeling of less than 12 square inches.
(ii) The label information includes a full list of ingredients in
accordance with regulations in this part.
(iii) The information required by paragraph (b) of this section
appears on the principal display panel or information panel label in
accordance with the provisions of this paragraph (c) except that the
type size is not less than \1/32\ inch in height.
(d) All information required to appear on the principal display
panel or on the information panel pursuant to this section shall appear
on the same panel unless there is insufficient space. In determining the
sufficiency of the available space, any vignettes, design,
[[Page 17]]
and other nonmandatory label information shall not be considered. If
there is insufficient space for all of this information to appear on a
single panel, it may be divided between these two panels except that the
information required pursuant to any given section or part shall all
appear on the same panel. A food whose label is required to bear the
ingredient statement on the principal display panel may bear all other
information specified in paragraph (b) of this section on the
information panel.
(e) All information appearing on the information panel pursuant to
this section shall appear in one place without other intervening
material.
(f) If the label of any package of food is too small to accommodate
all of the information required by Sec. Sec. 501.4, 501.5, 501.8, and
501.17, the Commissioner may establish by regulation an acceptable
alternative method of disseminating such information to the public,
e.g., a type size smaller than one-sixteenth inch in height, or labeling
attached to or inserted in the package or available at the point of
purchase. A petition requesting such a regulation, as an amendment to
this paragraph shall be submitted pursuant to part 10 of this chapter.
[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 4716, Jan. 25, 1977;
42 FR 15675, Mar. 22, 1977]
Sec. 501.3 Identity labeling of animal food in package form.
(a) The principal display panel of a food in package form shall bear
as one of its principal features a statement of the identity of the
commodity.
(b) Such statement of identity shall be in terms of:
(1) The name now or hereafter specified in or required by any
applicable Federal law or regulation; or, in the absence thereof,
(2) The common or usual name of the food; or, in the absence
thereof,
(3) An appropriately descriptive term, or when the nature of the
food is obvious, a fanciful name commonly used by the public for such
food.
(c) Where a food is marketed in various optional forms (whole,
slices, diced, etc.), the particular form shall be considered to be a
necessary part of the statement of identity and shall be declared in
letters of a type size bearing a reasonable relation to the size of the
letters forming the other components of the statement of identity;
except that if the optional form is visible through the container or is
depicted by an appropriate vignette, the particular form need not be
included in the statement. This specification does not affect the
required declarations of identity under definitions and standards for
foods promulgated pursuant to section 401 of the act.
(d) This statement of identity shall be presented in bold type on
the principal display panel, shall be in a size reasonably related to
the most prominent printed matter on such panel, and shall be in lines
generally parallel to the base on which the package rests as it is
designed to be displayed.
(e) Under the provisions of section 403(c) of the Federal Food,
Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it is
an imitation of another food unless its label bears, in type of uniform
size and prominence, the word imitation and, immediately thereafter, the
name of the food imitated.
(1) A food shall be deemed to be an imitation and thus subject to
the requirements of section 403(c) of the act if it is a substitute for
and resembles another food but is nutritionally inferior to that food.
(2) A food that is a substitute for and resembles another food shall
not be deemed to be an imitation provided it meets each of the following
requirements:
(i) It is not nutritionally inferior to the food for which it
substitutes and which it resembles.
(ii) Its label bears a common or usual name that complies with the
provisions of Sec. 502.5 of this chapter and that is not false or
misleading, or in the absence of an existing common or usual name, an
appropriately descriptive term that is not false or misleading. The
label may, in addition, bear a fanciful name which is not false or
misleading.
(3) A food for which a common or usual name is established by
regulation (e.g., in a standard of identity pursuant to section 401 of
the act, in a common or usual name regulation and may, in
[[Page 18]]
addition, bear a fanciful name which is not false or misleading, and
established pursuant to part 502 of this chapter), and which complies
with all of the applicable requirements of such regulation(s), shall not
be deemed to be an imitation.
(4) Nutritional inferiority includes:
(i) Any reduction in the content of an essential nutrient that is
present in a measurable amount.
(ii) If the Commissioner concludes that a food is a substitute for
and resembles another food but is inferior to the food imitated for
reasons other than those set forth in this paragraph, he may propose
appropriate revisions to this regulation or he may propose a separate
regulation governing the particular food.
(f) A label may be required to bear the percentage(s) of a
characterizing ingredient(s) or information concerning the presence or
absence of an ingredient(s) or the need to add an ingredient(s) as part
of the common or usual name of the food pursuant to part 502 of this
chapter.
[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977;
54 FR 18279, Apr. 28, 1989]
Sec. 501.4 Animal food; designation of ingredients.
(a) Ingredients required to be declared on the label of a food,
including foods that comply with standards of identity that require
labeling in compliance with this part 501, except those exempted by
Sec. 501.100, shall be listed by common or usual name in descending
order of predominance by weight on either the principal display panel or
the information panel in accordance with the provisions of Sec. 501.2.
(b) The name of an ingredient shall be a specific name and not a
collective (generic) name, except that:
(1) Spices, flavorings, colorings and chemical preservatives shall
be declared according to the provisions of Sec. 501.22.
(2) An ingredient which itself contains two or more ingredients and
which has an established common or usual name, conforms to a standard
established pursuant to the Meat Inspection or Poultry Products
Inspection Acts by the U.S. Department of Agriculture, or conforms to a
definition and standard of identity established pursuant to section 401
of the Federal Food, Drug, and Cosmetic Act, shall be designated in the
statement of ingredients on the label of such food by either of the
following alternatives:
(i) By declaring the established common or usual name of the
ingredient followed by a parenthetical listing of all ingredients
contained therein in descending order of predominance except that, if
the ingredient is a food subject to a definition and standard of
identity established in this subchapter E, only the ingredients required
to be declared by the definition and standard of identity need be
listed; or
(ii) By incorporating into the statement of ingredients in
descending order of predominance in the finished food, the common or
usual name of every component of the ingredient without listing the
ingredient itself.
(3) Skim milk, concentrated skim milk, reconstituted skim milk, and
nonfat dry milk may be declared as skim milk or nonfat milk.
(4) Milk, concentrated milk, reconstituted milk, and dry whole milk
may be declared as milk.
(5) Bacterial cultures may be declared by the word cultured followed
by the name of the substrate, e.g., made from cultured skim milk or
cultured buttermilk.
(6) Sweetcream buttermilk, concentrated sweetcream buttermilk,
reconstituted sweetcream buttermilk, and dried sweetcream buttermilk may
be declared as buttermilk.
(7) Whey, concentrated whey, reconstituted whey, and dried whey may
be declared as whey.
(8) Cream, reconstituted cream, dried cream, and plastic cream
(sometimes known as concentrated milkfat) may be declared as cream.
(9) Butteroil and anhydrous butterfat may be declared as butterfat.
(10) Dried whole eggs, frozen whole eggs, and liquid whole eggs may
be declared as eggs.
(11) Dried egg whites, frozen egg whites, and liquid egg whites may
be declared as egg whites.
(12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be
declared as egg yolks.
[[Page 19]]
(13) A livestock or poultry feed may be declared by a collective
name listed in Sec. 501.110 if it is an animal feed within the meaning
of section 201(w) of the act and meets the requirements for the use of a
collective name as prescribed in Sec. 501.110 for certain feed
ingredients.
(14) [Reserved]
(15) When all the ingredients of a wheat flour are declared in an
ingredient statement, the principal ingredient of the flour shall be
declared by the name(s) specified in Sec. Sec. 137.105, 137.200,
137.220, 137.225 of this chapter, i.e., the first ingredient designated
in the ingredient list of flour, or bromated flour, or enriched flour,
or self-rising flour is flour, white flour, wheat flour, or plain flour;
the first ingredient designated in the ingredient list of durum flour is
durum flour; the first ingredient designated in the ingredient list of
whole wheat flour, or bromated whole wheat flour is whole wheat flour,
graham flour, or entire wheat flour; and the first ingredient designated
in the ingredient list of whole durum wheat flour is whole durum wheat
flour.
(c) When water is added to reconstitute, completely or partially, an
ingredient permitted by paragraph (b) of this section to be declared by
a class name, the position of the ingredient class name in the
ingredient statement shall be determined by the weight of the
unreconstituted ingredient plus the weight of the quantity of water
added to reconstitute that ingredient, up to the amount of water needed
to reconstitute the ingredient to single strength. Any water added in
excess of the amount of water needed to reconstitute the ingredient to
single strength shall be declared as water in the ingredient statement.
[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977;
60 FR 38480, July 27, 1995]
Sec. 501.5 Animal food; name and place of business of manufacturer,
packer, or distributor.
(a) The label of a food in packaged form shall specify conspicuously
the name and place of business of the manufacturer, packer, or
distributor.
(b) The requirement for declaration of the name of the manufacturer,
packer, or distributor shall be deemed to be satisfied, in the case of a
corporation, only by the actual corporate name, which may be preceded or
followed by the name of the particular division of the corporation. In
the case of an individual, partnership, or association, the name under
which the business is conducted shall be used.
(c) Where the food is not manufactured by the person whose name
appears on the label, the name shall be qualified by a phrase that
reveals the connection such person has with such food; such as
``Manufactured for ------------,'' ``Distributed by ------------,'' or
any other wording that expresses the facts.
(d) The statement of the place of business shall include the street
address, city, state, and ZIP Code; however, the street address may be
omitted if it is shown in a current city directory or telephone
directory. The requirement for inclusion of the ZIP Code shall apply
only to consumer commodity labels developed or revised after the
effective date of this section. In the case of nonconsumer packages, the
ZIP Code shall appear either on the label or the labeling (including
invoice).
(e) If a person manufactures, packs, or distributes a food at a
place other than his principal place of business, the label may state
the principal place of business in lieu of the actual place where such
food was manufactured or packed or is to be distributed, unless such
statement would be misleading.
Sec. 501.8 Labeling of animal food with number of servings.
(a) The label of any package of a food which bears a representation
as to the number of servings contained in such package shall bear in
immediate conjunction with such statement, and in the same size type as
is used for such statement, a statement of the net quantity (in terms of
weight, measure, or numerical count) of each such serving; however, such
statement may be expressed in terms that differ from the terms used in
the required statement of net quantity of contents (for example,
cupfuls, tablespoonfuls, etc.) when such differing term is common to
cookery and describes a constant quantity.
[[Page 20]]
Such statement may not be misleading in any particular. A statement of
the number of units in a package is not in itself a statement of the
number of servings.
(b) If there exists a voluntary product standard promulgated
pursuant to the procedures found in 15 CFR part 10 by the Department of
Commerce, quantitatively defining the meaning of the term serving with
respect to a particular food, then any label representation as to the
number of servings in such packaged food shall correspond with such
quantitative definition. (Copies of published standards are available
upon request from the National Bureau of Standards, Department of
Commerce, Washington, DC 20234.)
Sec. 501.15 Animal food; prominence of required statements.
(a) A word, statement, or other information required by or under
authority of the act to appear on the label may lack that prominence and
conspicuousness required by section 403(f) of the act by reason (among
other reasons) of:
(1) The failure of such word, statement, or information to appear on
the part or panel of the label which is presented or displayed under
customary conditions of purchase;
(2) The failure of such word, statement, or information to appear on
two or more parts or panels of the label, each of which has sufficient
space therefor, and each of which is so designed as to render it likely
to be, under customary conditions of purchase, the part or panel
displayed;
(3) The failure of the label to extend over the area of the
container or package available for such extension, so as to provide
sufficient label space for the prominent placing of such word,
statement, or information;
(4) Insufficiency of label space (for the prominent placing of such
word, statement, or information) resulting from the use of label space
for any word, statement, design, or device which is not required by or
under authority of the act to appear on the label;
(5) Insufficiency of label space (for the prominent placing of such
word, statement, or information) resulting from the use of label space
to give materially greater conspicuousness to any other word, statement,
or information, or to any design or device; or
(6) Smallness or style of type in which such word, statement, or
information appears, insufficient background contrast, obscuring designs
or vignettes, or crowding with other written, printed, or graphic
matter.
(b) No exemption depending on insufficiency of label space, as
prescribed in regulations promulgated under section 403(e) or (i) of the
act, shall apply if such insufficiency is caused by:
(1) The use of label space for any word, statement, design, or
device which is not required by or under authority of the act to appear
on the label;
(2) The use of label space to give greater conspicuousness to any
word, statement, or other information that is required by section 403(f)
of the act; or
(3) The use of label space for any representation in a foreign
language.
(c)(1) All words, statements, and other information required by or
under authority of the act to appear on the label or labeling shall
appear thereon in the English language: Provided, however, That in the
case of articles distributed solely in the Commonwealth of Puerto Rico
or in a territory where the predominant language is one other than
English, the predominant language may be substituted for English.
(2) If the label contains any representation in a foreign language,
all words, statements, and other information required by or under
authority of the act to appear on the label shall appear thereon in the
foreign language.
(3) If any article of labeling (other than a label) contains any
representation in a foreign language, all words, statements, and other
information required by or under authority of the act to appear on the
label or labeling shall appear on such article of labeling.
Sec. 501.17 Animal food labeling warning statements.
(a) Self-pressurized containers. (1) The label of a food packaged in
a self-pressurized container and intended to be expelled from the
package under pressure shall bear the following warning:
[[Page 21]]
Warning Avoid spraying in eyes. Contents under pressure. Do not
puncture or incinerate. Do not store at temperature above 120 [deg]F.
Keep out of reach of children.
(2) In the case of products intended for use by children, the phrase
``except under adult supervision'' may be added at the end of the last
sentence in the warning required by paragraph (a)(1) of this section.
(3) In the case of products packaged in glass containers, the word
``break'' may be substituted for the word ``puncture'' in the warning
required by paragraph (a)(1) of this section.
(4) The words ``Avoid spraying in eyes'' may be deleted from the
warning required by paragraph (a)(1) of this section in the case of a
product not expelled as a spray.
(b) Self-pressurized containers with halocarbon or hydrocarbon
propellants. (1) In addition to the warning required by paragraph (a) of
this section, the label of a food packaged in a self-pressurized
container in which the propellant consists in whole or in part of a
halocarbon or a hydrocarbon shall bear the following warning:
Warning Use only as directed. Intentional misuse by deliberately
concentrating and inhaling the contents can be harmful or fatal.
(2) The warning required by paragraph (b)(1) of this section is not
required for the following products:
(i) Products expelled in the form of a foam or cream, which contain
less than 10 percent propellant in the container.
(ii) Products in a container with a physical barrier that prevents
escape of the propellant at the time of use.
(iii) Products of a net quantity of contents of less than 2 ozs that
are designed to release a measured amount of product with each valve
actuation.
(iv) Products of a net quantity of contents of less than \1/2\ oz.
(c) Animal food containing or manufactured with a chlorofluorocarbon
or other ozone-depleting substance. Labeling requirements for animal
foods that contain or are manufactured with a chlorofluorocarbon or
other ozone-depleting substance designated by the Environmental
Protection Agency (EPA) are set forth in 40 CFR part 82.
[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 22033, Apr. 29, 1977;
61 FR 20101, May 3, 1996]
Sec. 501.18 Misbranding of animal food.
(a) Among representations in the labeling of a food which render
such food misbranded is a false or misleading representation with
respect to another food or a drug, device, or cosmetic.
(b) The labeling of a food which contains two or more ingredients
may be misleading by reason (among other reasons) of the designation of
such food in such labeling by a name which includes or suggests the name
of one or more but not all such ingredients, even though the names of
all such ingredients are stated elsewhere in the labeling.
(c) Among representations in the labeling of a food which render
such food misbranded is any representation that expresses or implies a
geographical origin of the food or any ingredient of the food except
when such representation is either:
(1) A truthful representation of geographical origin.
(2) A trademark or trade name provided that as applied to the
article in question its use is not deceptively misdescriptive. A
trademark or trade name comprised in whole or in part of geographical
words shall not be considered deceptively misdescriptive if it:
(i) Has been so long and exclusively used by a manufacturer or
distributor that it is generally understood by the consumer to mean the
product of a particular manufacturer or distributor; or
(ii) Is so arbitrary or fanciful that it is not generally understood
by the consumer to suggest geographic origin.
(3) A part of the name required by applicable Federal law or
regulation.
(4) A name whose market significance is generally understood by the
consumer to connote a particular class, kind, type, or style of food
rather than to indicate geographical origin.
[[Page 22]]
Subpart B_Specific Animal Food Labeling Requirements
Sec. 501.22 Animal foods; labeling of spices, flavorings, colorings,
and chemical preservatives.
(a)(1) The term artificial flavor or artificial flavoring means any
substance, the function of which is to impart flavor, which is not
derived from a spice, fruit or fruit juice, vegetable or vegetable
juice, edible yeast, herb, bark, bud, root, leaf or similar plant
material, meat, fish, poultry, eggs, dairy products, or fermentation
products thereof. Artificial flavor includes the substances listed in
Sec. Sec. 172.515(b) and 582.60 of this chapter except where these are
derived from natural sources.
(2) The term spice means any aromatic vegetable substance in the
whole, broken, or ground form, except for those substances which have
been traditionally regarded as foods, such as onions, garlic and celery;
whose significant function in food is seasoning rather than nutritional;
that is true to name; and from which no portion of any volatile oil or
other flavoring principle has been removed. Spices include the spices
listed in subpart A of part 582 of this chapter, such as the following:
Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery seed,
Chervil, Cinnamon, Cloves, Coriander, Cumin seed, Dill seed, Fennel
seed, Fenugreek, Ginger, Horseradish, Mace, Marjoram, Mustard flour,
Nutmeg, Oregano, Paprika, Parsley, Pepper, black; Pepper, white; Pepper,
red; Rosemary, Saffron, Sage, Savory, Star aniseed, Tarragon, Thyme,
Turmeric.
Paprika, turmeric, and saffron or other spices which are also colors,
shall be declared as spice and coloring unless declared by their common
or usual name.
(3) The term natural flavor or natural flavoring means the essential
oil, oleoresin, essence or extractive, protein hydrolysate, distillate,
or any product of roasting, heating or enzymolysis, which contains the
flavoring constituents derived from a spice, fruit or fruit juice,
vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf
or similar plant material, meat, seafood, poultry, eggs, dairy products,
or fermentation products thereof, whose significant function in food is
flavoring rather than nutritional. Natural flavors, include the natural
essence or extractives obtained from plants listed in subpart A of part
582 of this chapter, and the substances listed in Sec. 172.510 of this
chapter.
(4) The term artificial color or artificial coloring means any color
additive as defined in Sec. 70.3(f) of this chapter.
(5) The term chemical preservative means any chemical that, when
added to food, tends to prevent or retard deterioration thereof, but
does not include common salt, sugars, vinegars, spices, or oils
extracted from spices, substances added to food by direct exposure
thereof to wood smoke, or chemicals applied for their insecticidal or
herbicidal properties.
(b) A food which is subject to the requirements of section 403(k) of
the act shall bear labeling, even though such food is not in package
form.
(c) A statement of artificial flavoring, artificial coloring, or
chemical preservative shall be placed on the food, or on its container
or wrapper, or on any two or all of these, as may be necessary to render
such statement likely to be read by the ordinary individual under
customary conditions of purchase and use of such food.
(d) A food shall be exempt from compliance with the requirements of
section 403(k) of the act if it is not in package form and the units
thereof are so small that a statement of artificial flavoring,
artificial coloring, or chemical preservative, as the case may be,
cannot be placed on such units with such conspicuousness as to render it
likely to be read by the ordinary individual under customary conditions
of purchase and use.
(e) A food shall be exempt while held for sale from the requirements
of section 403(k) of the act (requiring label statement of any
artificial flavoring, artificial coloring, or chemical preservatives) if
said food, having been received in bulk containers at a retail
establishment, is displayed to the purchaser with either (1) the
labeling of the bulk container plainly in view or (2) a counter card,
sign, or other appropriate device bearing prominently and conspicuously
the information required to be stated on the label pursuant to section
403(k) of the act.
[[Page 23]]
(f) A fruit or vegetable shall be exempt from compliance with the
requirements of section 403(k) of the act with respect to a chemical
preservative applied to the fruit or vegetable as a pesticide chemical
prior to harvest.
(g) A flavor shall be labeled in the following way when shipped to a
food manufacturer or processor (but not a consumer) for use in the
manufacture of a fabricated food, unless it is a flavor for which a
standard of identity has been promulgated, in which case it shall be
labeled as provided in the standard:
(1) If the flavor consists of one ingredient, it shall be declared
by its common or usual name.
(2) If the flavor consists of two or more ingredients, the label
either may declare each ingredient by its common or usual name or may
state ``All flavor ingredients contained in this product are approved
for use in a regulation of the Food and Drug Administration.'' Any
flavor ingredient not contained in one of these regulations, and any
nonflavor ingredient, shall be separately listed on the label.
(3) In cases where the flavor contains a solely natural flavor(s),
the flavor shall be so labeled, e.g., strawberry flavor, banana flavor,
or natural strawberry flavor. In cases where the flavor contains both a
natural flavor and an artificial flavor, the flavor shall be so labeled,
e.g., natural and artificial strawberry flavor. In cases where the
flavor contains a solely artificial flavor(s), the flavor shall be so
labeled, e.g., artificial strawberry flavor.
(h) The label of a food to which flavor is added shall declare the
flavor in the statement of ingredients in the following way:
(1) Spice, natural flavor, and artificial flavor may be declared as
spice, natural flavor, or artificial flavor, or any combination thereof,
as the case may be.
(2) An incidental additive in a food, originating in a spice or
flavor used in the manufacture of the food, need not be declared in the
statement of ingredients if it meets the requirements of Sec.
501.100(a)(3).
(3) Substances obtained by cutting, grinding, drying, pulping, or
similar processing of tissues derived from fruit, vegetable, meat, fish,
or poultry, e.g., powdered or granulated onions, garlic powder, and
celery powder, are commonly understood by consumers to be food rather
than flavor and shall be declared by their common or usual name.
(4) Any salt (sodium chloride) used as an ingredient in food shall
be declared by its common or usual name salt.
(5) Any monosodium glutamate used as an ingredient in food shall be
declared by its common or usual name monosodium glutamate.
(6) Any pyroligneous acid or other artificial smoke flavors used as
an ingredient in a food may be declared as artificial flavor or
artificial smoke flavor. No representation may be made, either directly
or implied, that a food flavored with pyroligneous acid or other
artificial smoke flavor has been smoked or has a true smoked flavor, or
that a seasoning sauce or similar product containing pyroligneous acid
or other artificial smoke flavor and used to season or flavor other
foods will result in a smoked product or one having a true smoked
flavor.
(i) If the label, labeling, or advertising of a food makes any
direct or indirect representations with respect to the primary
recognizable flavor(s), by word, vignette, e.g., depiction of a fruit,
or other means, or if for any other reason the manufacturer or
distributor of a food wishes to designate the type of flavor in the food
other than through the statement of ingredients, such flavor shall be
considered the characterizing flavor and shall be declared in the
following way:
(1) If the food contains no artificial flavor which simulates,
resembles or reinforces the characterizing flavor, the name of the food
on the principal display panel or panels of the label shall be
accompanied by the common or usual name of the characterizing flavor in
letters not less than one-half the height of the letters used in the
name of the food, except that:
(i) If the food is one that is commonly expected to contain a
characterizing food ingredient, and the food contains natural flavor
derived from such ingredient and an amount of characterizing ingredient
insufficient to independently characterize the food, or the food
contains no such ingredient, the
[[Page 24]]
name of the characterizing flavor may be immediately preceded by the
word natural and shall be immediately followed by the word flavored in
letters not less than one-half the height of the letters in the name of
the characterizing flavor.
(ii) If none of the natural flavor used in the food is derived from
the product whose flavor is simulated, the food in which the flavor is
used shall be labeled either with the flavor of the product from which
the flavor is derived or as artificially flavored.
(iii) If the food contains both a characterizing flavor from the
product whose flavor is simulated and other natural flavor which
simulates, resembles or reinforces the characterizing flavor, the food
shall be labeled in accordance with the introductory text and paragraph
(i)(1)(i) of this section and the name of the food shall be immediately
followed by the words with other natural flavor in letters not less than
one-half the height of the letters used in the name of the
characterizing flavor.
(2) If the food contains any artificial flavor which simulates,
resembles or reinforces the characterizing flavor, the name of the food
on the principal display panel or panels of the label shall be
accompanied by the common or usual name(s) of the characterizing flavor,
in letters not less than one-half the height of the letters used in the
name of the food and the name of the characterizing flavor shall be
accompanied by the word(s) artificial or artificially flavored, in
letters not less than one-half the height of the letters in the name of
the characterizing flavor.
(3) Wherever the name of the characterizing flavor appears on the
label (other than in the statement of ingredients) so conspicuously as
to be easily seen under customary conditions of purchase, the words
prescribed by this paragraph shall immediately and conspicuously precede
or follow such name, without any intervening written, printed, or
graphic matter, except:
(i) Where the characterizing flavor and a trademark or brand are
presented together, other written, printed, or graphic matter that is a
part of or is associated with the trademark or brand may intervene if
the required words are in such relationship with the trademark or brand
as to be clearly related to the characterizing flavor; and
(ii) If the finished product contains more than one flavor subject
to the requirements of this paragraph, the statements required by this
paragraph need appear only once in each statement of characterizing
flavors present in such food.
(iii) If the finished product contains three or more distinguishable
characterizing flavors, or a blend of flavors with no primary
recognizable flavor, the flavor may be declared by an appropriately
descriptive generic term in lieu of naming each flavor.
(4) A flavor supplier shall certify, in writing, that any flavor he
supplies which is designated as containing no artificial flavor does
not, to the best of his knowledge and belief, contain any artificial
flavor, and that he has added no artificial flavor to it. The
requirement for such certification may be satisfied by a guarantee under
section 303(c)(2) of the act which contains such a specific statement. A
flavor used shall be required to make such a written certification only
where he adds to or combines another flavor with a flavor which has been
certified by a flavor supplier as containing no artificial flavor, but
otherwise such user may rely upon the supplier's certification and need
make no separate certification. All such certifications shall be
retained by the certifying party throughout the period in which the
flavor is supplied and for a minimum of 3 years thereafter, and shall be
subject to the following conditions:
(i) The certifying party shall make such certifications available
upon request at all reasonable hours to any duly authorized officer, or
employee of the Food and Drug Administration or any other employee
acting on behalf of the Secretary of Health and Human Services. Such
certifications are regarded by the Food and Drug Administration as
reports to the government and as guarantees or other undertakings within
the meaning of section 301(h) of the act and subject the certifying
party to the penalties for making any false report to the government
under 18 U.S.C. 1001 and any false guarantee or undertaking under
section
[[Page 25]]
303(a) of the act. The defenses provided under section 303(c)(2) of the
act shall be applicable to the certifications provided for in this
section.
(ii) Wherever possible, the Food and Drug Administration shall
verify the accuracy of a reasonable number of certifications made
pursuant to this section, constituting a representative sample of such
certifications, and shall not request all such certifications.
(iii) Where no person authorized to provide such information is
reasonably available at the time of inspection, the certifying party
shall arrange to have such person and the relevant materials and records
ready for verification as soon as practicable; provided that, whenever
the Food and Drug Administration has reason to believe that the supplier
or user may utilize this period to alter inventories or records, such
additional time shall not be permitted. Where such additional time is
provided, the Food and Drug Administration may require the certifying
party to certify that relevant inventories have not been materially
disturbed and relevant records have not been altered or concealed during
such period.
(iv) The certifying party shall provide, to an officer or
representative duly designated by the Secretary, such qualitative
statement of the composition of the flavor or product covered by the
certification as may be reasonably expected to enable the Secretary's
representatives to determine which relevant raw and finished materials
and flavor ingredient records are reasonably necessary to verify the
certifications. The examination conducted by the Secretary's
representative shall be limited to inspection and review of inventories
and ingredient records for those certifications which are to be
verified.
(v) Review of flavor ingredient records shall be limited to the
qualitative formula and shall not include the quantitative formula. The
person verifying the certifications may make only such notes as are
necessary to enable him to verify such certification. Only such notes or
such flavor ingredient records as are necessary to verify such
certification or to show a potential or actual violation may be removed
or transmitted from the certifying party's place of business: Provided,
That, where such removal or transmittal is necessary for such purposes
the relevant records and notes shall be retained as separate documents
in Food and Drug Administration files, shall not be copied in other
reports, and shall not be disclosed publicly other than in a judicial
proceeding brought pursuant to the act or 18 U.S.C. 1001.
(j) A food to which a chemical preservative(s) is added shall,
except when exempt pursuant to Sec. 501.100, bear a label declaration
stating both the common or usual name of the ingredient(s) and a
separate description of its function, e.g., preservative, to retard
spoilage, a mold inhibitor, to help protect flavor or to promote color
retention.
[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977;
42 FR 15675, Mar. 22, 1977]
Subparts C-E [Reserved]
Subpart F_Exemptions From Animal Food Labeling Requirements
Sec. 501.100 Animal food; exemptions from labeling.
(a) The following foods are exempt from compliance with the
requirements of section 403(i)(2) of the act (requiring a declaration on
the label of the common or usual name of each ingredient when the food
is fabricated from two or more ingredients).
(1) An assortment of different items of food, when variations in the
items that make up different packages packed from such assortment
normally occur in good packing practice and when such variations result
in variations in the ingredients in different packages, with respect to
any ingredient that is not common to all packages. Such exemption,
however, shall be on the condition that the label shall bear, in
conjunction with the names of such ingredients as are common to all
packages, a statement (in terms that are as informative as practicable
and that are not misleading) indicating by name other ingredients which
may be present.
[[Page 26]]
(2) A food having been received in bulk containers at a retail
establishment, if displayed to the purchaser with either (i) the
labeling of the bulk container plainly in view or (ii) a counter card,
sign, or other appropriate device bearing prominently and conspicuously
the information required to be stated on the label pursuant to section
403(i)(2) of the act.
(3) Incidental additives that are present in a food at insignificant
levels and do not have any technical or functional effect in that food.
For the purposes of this paragraph (a)(3), incidental additives are:
(i) Substances that have no technical or functional effect but are
present in a food by reason of having been incorporated into the food as
an ingredient of another food, in which the substance did have a
functional or technical effect.
(ii) Processing aids, which are as follows:
(a) Substances that are added to a food during the processing of
such food but are removed in some manner from the food before it is
packaged in its finished form.
(b) Substances that are added to a food during processing, are
converted into constituents normally present in the food, and do not
significantly increase the amount of the constituents naturally found in
the food.
(c) Substances that are added to a food for their technical or
functional effect in the processing but are present in the finished food
at insignificant levels and do not have any technical or functional
effect in that food.
(iii) Substances migrating to food from equipment or packaging or
otherwise affecting food that are not food additives as defined in
section 201(s) of the act; or if they are food additives as so defined,
they are used in conformity with regulations established pursuant to
section 409 of the act.
(b) A food repackaged in a retail establishment is exempt from the
following provisions of the act if the conditions specified are met.
(1) Section 403(e)(1) of the act (requiring a statement on the label
of the name and place of business of the manufacturer, packer, or
distributor).
(2) Section 403(g)(2) of the act (requiring the label of a food
which purports to be or is represented as one for which a definition and
standard of identity has been prescribed to bear the name of the food
specified in the definition and standard and, insofar as may be required
by the regulation establishing the standard the common names of the
optional ingredients present in the food), if the food is displayed to
the purchaser with its interstate labeling clearly in view, or with a
counter card, sign, or other appropriate device bearing prominently and
conspicuously the information required by these provisions.
(3) Section 403(i)(1) of the act (requiring the label to bear the
common or usual name of the food), if the food is displayed to the
purchaser with its interstate labeling clearly in view, or with a
counter card, sign, or other appropriate device bearing prominently and
conspicuously the common or usual name of the food, or if the common or
usual name of the food is clearly revealed by its appearance.
(c) [Reserved]
(d) Except as provided by paragraphs (e) and (f) of this section, a
shipment or other delivery of a food which is, in accordance with the
practice of the trade, to be processed, labeled, or repacked in
substantial quantity at an establishment other than that where
originally processed or packed, shall be exempt, during the time of
introduction into and movement in interstate commerce and the time of
holding in such establishment, from compliance with the labeling
requirements of section 403 (c), (e), (g), (h), (i), (j) and (k) of the
act if:
(1) The person who introduced such shipment or delivery into
interstate commerce is the operator of the establishment where such food
is to be processed, labeled, or repacked; or
(2) In case such person is not such operator, such shipment or
delivery is made to such establishment under a written agreement, signed
by and containing the post office addresses of such person and such
operator, and containing such specifications for the processing,
labeling, or repacking, as the case may be, of such food in such
establishment as will ensure, if such specifications are followed, that
such
[[Page 27]]
food will not be adulterated or misbranded within the meaning of the act
upon completion of such processing, labeling, or repacking. Such person
and such operator shall each keep a copy of such agreement until 2 years
after the final shipment or delivery of such food from such
establishment, and shall make such copies available for inspection at
any reasonable hour to any officer or employee of the Department who
requests them.
(e) Conditions affecting expiration of exemptions.
(1) An exemption of a shipment or other delivery of a food under
paragraph (d)(1) of this section shall, at the beginning of the act of
removing such shipment or delivery, or any part thereof, from such
establishment become void ab initio if the food comprising such
shipment, delivery, or part is adulterated or misbranded within the
meaning of the act when so removed.
(2) An exemption of a shipment or other delivery of a food under
paragraph (d)(2) of this section shall become void ab initio with
respect to the person who introduced such shipment or delivery into
interstate commerce upon refusal by such person to make available for
inspection a copy of the agreement, as required by paragraph (d)(2) of
this section.
(3) An exemption of a shipment or other delivery of a food under
paragraph (d)(2) of this section shall expire:
(i) At the beginning of the act of removing such shipment or
delivery, or any part thereof, from such establishment if the food
comprising such shipment, delivery, or part is adulterated or misbranded
within the meaning of the act when so removed; or
(ii) Upon refusal by the operator of the establishment where such
food is to be processed, labeled, or repacked, to make available for
inspection a copy of the agreement as required by such paragraph.
(f) [Reserved]
(g) The label declaration of a harmless marker used to identify a
particular manufacturer's product may result in unfair competition
through revealing a trade secret. Exemption from the label declaration
of such a marker is granted, therefore, provided that the following
conditions are met:
(1) The person desiring to use the marker without label declaration
of its presence has submitted to the Commissioner of Food and Drugs full
information concerning the proposed usage and the reasons why he
believes label declaration of the marker should be subject to this
exemption; and
(2) The person requesting the exemption has received from the
Commissioner of Food and Drugs a finding that the marker is harmless and
that the exemption has been granted.
Sec. 501.103 Petitions requesting exemptions from or special requirements
for label declaration of ingredients.
The Commissioner of Food and Drugs, either on his own initiative or
on behalf of any interested person who has submitted a petition pursuant
to part 10 of this chapter may issue a proposal to amend Sec. 501.4 to
specify the manner in which an ingredient(s) shall be declared, i.e., by
specific or class name, or Sec. 501.100 to exempt an ingredient(s) from
the requirements for label declaration.
[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 15675, Mar. 22, 1977]
Sec. 501.105 Declaration of net quantity of contents when exempt.
(a) The principal display panel of a food in package form shall bear
a declaration of the net quantity of contents. This shall be expressed
in the terms of weight, measure, numerical count, or a combination of
numerical count and weight or measure. The statement shall be in terms
of fluid measure if the food is liquid, or in terms of weight if the
food is solid, semisolid, or viscous, or a mixture of solid and liquid;
except that such statement may be in terms of dry measure if the food is
a fresh fruit, fresh vegetable, or other dry commodity that is
customarily sold by dry measure. If there is a firmly established
general consumer usage and trade custom of declaring the contents of a
liquid by weight, or a solid, semisolid, or viscous product by fluid
measure, it may be used. Whenever the Commissioner determines that an
existing practice of declaring net quantity of contents by
[[Page 28]]
weight, measure, numerical count, or a combination in the case of a
specific packaged food does not facilitate value comparisons by
consumers and offers opportunity for consumer confusion, he will by
regulation designate the appropriate term or terms to be used for such
commodity.
(b)(1) Statements of weight shall be in terms of avoirdupois pound
and ounce.
(2) Statements of fluid measure shall be in terms of the U.S. gallon
of 231 cubic inches and quart, pint, and fluid ounce subdivisions
thereof, and shall:
(i) In the case of frozen food that is sold and consumed in a frozen
state, express the volume at the frozen temperature.
(ii) In the case of refrigerated food that is sold in the
refrigerated state, express the volume at 40 [deg]F (4 [deg]C).
(iii) In the case of other foods, express the volume at 68 [deg]F
(20 [deg]C).
(3) Statements of dry measure shall be in terms of the U.S. bushel
of 2,150.42 cubic inches and peck, dry quart, and dry pint subdivisions
thereof.
(c) When the declaration of quantity of contents by numerical count
does not give adequate information as to the quantity of food in the
package, it shall be combined with such statement of weight, measure, or
size of the individual units of the foods as will provide such
information.
(d) The declaration may contain common or decimal fractions. A
common fraction shall be in terms of halves, quarters, eighths,
sixteenths, or thirty-seconds; except that if there exists a firmly
established general consumer usage and trade custom of employing
different common fractions in the net quantity declaration of a
particular commodity, they may be employed. A common fraction shall be
reduced to its lowest terms; a decimal fraction shall not be carried out
to more than two places. A statement that includes small fractions of an
ounce shall be deemed to permit smaller variations than one which does
not include such fractions.
(e) The declaration shall be located on the principal display panel
of the label, and with respect to packages bearing alternate principal
panels it shall be duplicated on each principal display panel.
(f) The declaration shall appear as a distinct item on the principal
display panel, shall be separated (by at least a space equal to the
height of the lettering used in the declaration) from other printed
label information appearing above or below the declaration and (by at
least a space equal to twice the width of the letter ``N'' of the style
of type used in the quantity of contents statement) from other printed
label information appearing to the left or right of the declaration. It
shall not include any term qualifying a unit of weight, measure, or
count (such as jumbo quart and full gallon) that tends to exaggerate the
amount of the food in the container. It shall be placed on the principal
display panel within the bottom 30 percent of the area of the label
panel in lines generally parallel to the base on which the package rests
as it is designed to be displayed: Provided, That on packages having a
principal display panel of 5 square inches or less, the requirement for
placement within the bottom 30 percent of the area of the label panel
shall not apply when the declaration of net quantity of contents meets
the other requirements of this part.
(g) The declaration shall accurately reveal the quantity of food in
the package exclusive of wrappers and other material packed therewith;
provided that in the case of foods packed in containers designed to
deliver the food under pressure, the declaration shall state the net
quantity of the contents that will be expelled when the instructions for
use as shown on the container are followed. The propellant is included
in the net quantity declaration.
(h) The declaration shall appear in conspicuous and easily legible
boldface print or type in distinct contrast (by typography, layout,
color, embossing, or molding) to other matter on the package; except
that a declaration of net quantity blown, embossed, or molded on a glass
or plastic surface is permissible when all label information is so
formed on the surface. Requirements of conspicuousness and legibility
shall include the specifications that:
[[Page 29]]
(1) The ratio of height to width (of the letter) shall not exceed a
differential of 3 units to 1 unit (no more than 3 times as high as it is
wide).
(2) Letter heights pertain to upper case or capital letters. When
upper and lower case or all lower case letters are used, it is the lower
case letter ``o'' or its equivalent that shall meet the minimum
standards.
(3) When fractions are used, each component numeral shall meet one-
half the minimum height standards.
(i) The declaration shall be in letters and numerals in a type size
established in relationship to the area of the principal display panel
of the package and shall be uniform for all packages of substantially
the same size by complying with the following type specifications:
(1) Not less than \1/16\ inch in height on packages the principal
display panel of which has an area of 5 square inches or less.
(2) Not less than \1/8\ inch in height on packages the principal
display panel of which has an area of more than 5 but not more than 25
square inches.
(3) Not less than \3/16\ inch in height on packages the principal
display panel of which has an area of more than 25 but not more than 100
square inches.
(4) Not less than \1/4\ inch in height on packages the principal
display panel of which has an area of more than 100 square inches,
except not less than \1/2\ inch in height if the area is more than 400
square inches.
Where the declaration is blown, embossed, or molded on a glass or
plastic surface rather than by printing, typing, or coloring, the
lettering sizes specified in paragraphs (i) (1) through (4) of this
section shall be increased by \1/16\ of an inch.
(j) On packages containing less than 4 pounds or 1 gallon and
labeled in terms of weight or fluid measure:
(1) The declaration shall be expressed both in ounces, with
identification by weight or by liquid measure and, if applicable (1
pound or 1 pint or more) followed in parentheses by a declaration in
pounds for weight units, with any remainder in terms of ounces or common
or decimal fractions of the pound (see examples set forth in paragraphs
(m) (1) and (2) of this section), or in the case of liquid measure, in
the largest whole units (quarts, quarts and pints, or pints, as
appropriate) with any remainder in terms of fluid ounces or common or
decimal fractions of the pint or quart (see examples in paragraphs (m)
(3) and (4) of this section).
(2) If the net quantity of contents declaration appears on a random
package, that is a package which is one of a lot, shipment, or delivery
of packages of the same consumer commodity with varying weights and with
no fixed weight pattern, it may, when the net weight exceeds 1 pound, be
expressed in terms of pounds and decimal fractions of the pound carried
out to not more than two decimal places. When the net weight does not
exceed 1 pound, the declaration on the random package may be in decimal
fractions of the pound in lieu of ounces (see example in paragraph
(m)(5) of this section).
(3) The declaration may appear in more than one line. The term net
weight shall be used when stating the net quantity of contents in terms
of weight. Use of the terms net or net contents in terms of fluid
measure or numerical count is optional. It is sufficient to distinguish
avoirdupois ounce from fluid ounce through association of terms; for
example, Net wt. 6 oz. or 6 oz. net wt. and 6 fl. oz. or net contents 6
fl. oz.
(k) On packages containing 4 pounds or 1 gallon or more and labeled
in terms of weight or fluid measure, the declaration shall be expressed
in pounds for weight units with any remainder in terms of ounces or
common or decimal fraction of the pound, or in the case of fluid
measure, it shall be expressed in the largest whole unit (gallons
followed by common or decimal fraction of a gallon or by the next
smaller whole unit or units (quarts, or quarts and pints)) with any
remainder in terms of fluid ounces or common or decimal fractions of the
pint or quart (see paragraph (m)(6) of this section).
(l) [Reserved]
(m) Examples: (1) A declaration of 1\1/2\ pounds weight shall be
expressed as Net Wt. 24 oz. (1 lb. 8 oz.), Net Wt. 24 oz. (1\1/2\ lb.),
or Net Wt. 24 oz. (1.5 lb.).
(2) A declaration of \3/4\ pound avoirdupois weight shall be
expressed as Net Wt. 12 oz.
[[Page 30]]
(3) A declaration of 1 quart liquid measure shall be expressed as
Net 32 fl. oz. (1 qt.).
(4) A declaration of 1\3/4\ quarts liquid measure shall be expressed
as Net contents 56 fluid ounces (1 quart 1\1/2\ pints) or as Net 56
fluid oz. (1 qt. 1 pt. 8 oz.), but not in terms of quart and ounce such
as Net 56 fluid oz. (1 quart 24 ounces).
(5) On a random package, declaration of \3/4\ pound avoirdupois may
be expressed as Net Wt. .75 lb.
(6) A declaration of 2\1/2\ gallons liquid measure shall be
expressed as Net contents 2\1/2\ gallons, Net contents 2.5 gallons, or
Net contents 2 gallons 2 quarts and not as 2 gallons 4 pints.
(n) For quantities, the following abbreviations and none other may
be employed (periods and plural forms are optional):
weight wt.
ounce oz.
pound lb.
gallon gal.
pint pt.
quart qt.
fluid fl.
(o) Nothing in this section shall prohibit supplemental statements
at locations other than the principal display panel(s) describing in
nondeceptive terms the net quantity of contents; provided, that such
supplemental statements of net quantity of contents shall not include
any term qualifying a unit of weight, measure, or count that tends to
exaggerate the amount of the food contained in the package; for example,
jumbo quart and full gallon. Dual or combination declarations of net
quantity of contents as provided for in paragraphs (a), (c), and (j) of
this section (for example, a combination of net weight plus numerical
count, net contents plus dilution directions of a concentrate, etc.) are
not regarded as supplemental net quantity statements and may be located
on the principal display panel.
(p) A separate statement of the net quantity of contents in terms of
the metric system is not regarded as a supplemental statement and an
accurate statement of the net quantity of contents in terms of the
metric system of weight or measure may also appear on the principal
display panel or on other panels.
(q) The declaration of net quantity of contents shall express an
accurate statement of the quantity of contents of the package.
Reasonable variations caused by loss or gain of moisture during the
course of good distribution practice or by unavoidable deviations in
good manufacturing practice will be recognized. Variations from stated
quantity of contents shall not be unreasonably large.
(r) [Reserved]
(s) On a multiunit retail package, a statement of the quantity of
contents shall appear on the outside of the package and shall include
the number of individual units, the quantity of each individual unit,
and, in parentheses, the total quantity of contents of the multiunit
package in terms of avoirdupois or fluid ounces, except that such
declaration of total quantity need not be followed by an additional
parenthetical declaration in terms of the largest whole units and
subdivisions thereof, as required by paragraph (j)(1) of this section. A
multiunit retail package may thus be properly labeled: 6-16 oz.
bottles--(96 fl. oz.) or 3-16 oz. cans--(net wt. 48 oz). For the
purposes of this section, multiunit retail package means a package
containing two or more individually packaged units of the identical
commodity and in the same quantity, intended to be sold as part of the
multiunit retail package but capable of being individually sold in full
compliance with all requirements of the regulations in this part. Open
multiunit retail packages that do not obscure the number of units nor
prevent examination of the labeling on each of the individual units are
not subject to this paragraph if the labeling of each individual unit
complies with the requirements of paragraphs (f) and (i) of this
section.
(t) Where the declaration of net quantity of contents is in terms of
net weight and/or drained weight or volume and does not accurately
reflect the actual quantity of the contents or the product falls below
the applicable standard of fill of container because of equipment
malfunction or otherwise unintentional product variation, and the label
conforms in all other respects to the requirements of this chapter
(except the requirement that food falling below the applicable standard
of fill of container shall bear the general statement of substandard
fill specified in
[[Page 31]]
Sec. 564.14(b) of this chapter), the mislabeled food product, including
any food product that fails to bear the general statement of substandard
fill specified in Sec. 564.14(b) of this chapter, may be sold by the
manufacturer or processor directly to institutions operated by Federal,
State or local governments: Provided, That:
(1) The purchaser shall sign a statement at the time of sale stating
that he is aware that the product is mislabeled to include
acknowledgement of the nature and extent of the mislabeling, e.g.,
``Actual net weight may be as low as ----% below labeled quantity'' and
that any subsequent distribution by him of said product except for his
own institutional use is unlawful. This statement shall be kept on file
at the principal place of business of the manufacturer or processor for
2 years subsequent to the date of shipment of the product and shall be
available to the Food and Drug Administration upon request.
(2) The product shall be labeled on the outside of its shipping
container with the statement(s):
(i) When the variation concerns net weight and/or drained weight of
volume--``Product Mislabeled. Actual net weight (drained weight or
volume where appropriate) may be as low as ----% below labeled quantity.
This Product Not for Retail Distribution,'' the blank to be filled in
with the maximum percentage variance between the labeled and actual
weight or volume of contents of the individual packages in the shipping
container, and
(ii) When the variation is in regard to a fill of container
standard--``Product Mislabeled. Actual fill may be as low as ----% below
standard of fill. This Product Not for Retail Distribution.''
(3) The statements required by paragraphs (t)(2) (i) and (ii) of
this section, which may be consolidated where appropriate, shall appear
prominently and conspicuously as compared to other printed matter on the
shipping container and in boldface print or type on a clear, contrasting
background in order to render them likely to be read and understood by
the purchaser under ordinary conditions of purchase.
[41 FR 38619, Sept. 10, 1976, as amended at 54 FR 18279, Apr. 28, 1989]
Sec. 501.110 Animal feed labeling; collective names for feed ingredients.
(a) An animal feed shall be exempt from the requirements of section
403(i)(2) of the act with respect to its label bearing the common or
usual names of the animal feed ingredients listed in paragraph (b) of
this section under the following prescribed conditions:
(1) The animal feed is intended solely for livestock and poultry.
(2) The label of the animal feed bears the collective name(s)
prescribed in paragraph (b) of this section in lieu of the corresponding
common or usual names of the individual feed ingredients contained
therein.
(3) The label of the animal feed otherwise conforms to the
requirements of section 403(i)(2) of the act.
(4) The ingredients of any feed listed in paragraph (b) of this
section neither contain nor are food additives as defined in section
201(s) of the act unless provided for by and in conformity with
applicable regulations established pursuant to section 409 of the act.
(b) Each collective name referred to in this paragraph may be used
for the purpose of labeling where one or more of the ingredients listed
for that collective name are present. The animal feed ingredients listed
under each of the collective names are the products defined by the
Association of American Feed Control Officials. The collective names are
as follows:
(1) Animal protein products include one or more of the following:
Animal products, marine products, and milk products.
(2) Forage products include one or more of the following: Alfalfa
meals, entire plant meals, hays, and stem meals.
(3) Grain products include one or more of the following: Barley,
grain sorghums, maize (corn), oats, rice, rye, and wheat.
(4) Plant protein products include one or more of the following:
Algae meals, coconut meals (copra), cottonseed meals, guar meal, linseed
meals, peanut meals, safflower meals, soybean meals, sunflower meals,
and yeasts.
(5) Processed grain byproducts include one or more of the following:
Brans, brewers dried grains, distillers grains,
[[Page 32]]
distillers solubles, flours, germ meals, gluten feeds, gluten meals,
grits, groats, hominy feeds, malt sprouts, middlings, pearled,
polishings, shorts, and wheat mill run.
(6) Roughage products include one or more of the following: Cobs,
hulls, husks, pulps, and straws.
PART 502_COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS--Table
of Contents
Sec.
502.5 General principles.
502.19 Petitions.
Authority: 21 U.S.C. 321, 343, 371.
Sec. 502.5 General principles.
(a) The common or usual name of a food, which may be a coined term,
shall accurately identify or describe, in as simple and direct terms as
possible, the basic nature of the food or its characterizing properties
or ingredients. The name shall be uniform among all identical or similar
products and may not be confusingly similar to the name of any other
food that is not reasonably encompassed within the same name. Each class
or subclass of food shall be given its own common or usual name that
states, in clear terms, what it is in a way that distinguishes it from
different foods.
(b) The common or usual name of a food shall include the
percentage(s) of any characterizing ingredient(s) or component(s) when
the proportion of such ingredient(s) or component(s) in the food has a
material bearing on price or consumer acceptance or when the labeling or
the appearance of the food may otherwise create an erroneous impression
that such ingredient(s) or component(s) is present in an amount greater
than is actually the case. The following requirements shall apply unless
modified by a specific regulation in this part.
(1) The percentage of a characterizing ingredient or component shall
be declared on the basis of its quantity in the finished product (i.e.,
weight/weight in the case of solids, or volume/volume in the case of
liquids).
(2) The percentage of a characterizing ingredient or component shall
be declared by the words ``containing (or contains) ---- percent (or %)
----'' or ``---- percent (or %) ----'' with the first blank filled in
with the percentage expressed as a whole number not greater than the
actual percentage of the ingredient or component named and the second
blank filled in with the common or usual name of the ingredient or
component. The word ``containing'' (or ``contains''), when used, shall
appear on a line immediately below the part of the common or usual name
of the food required by paragraph (a) of this section. For each
characterizing ingredient or component, the words ``---- percent (or %)
----''shall appear following or directly below the word ``containing''
(or ``contains''), or directly below the part of the common or usual
name of the food required by paragraph (a) of this section when the word
``containing'' (or ``contains'') is not used, in easily legible boldface
print or type in distinct contrast to other printed or graphic matter,
and in a height not less than the larger of the following alternatives:
(i) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(ii) Not less than one-half the height of the largest type appearing
in the part of the common or usual name of the food required by
paragraph (a) of this section.
(c) The common or usual name of a food shall include a statement of
the presence or absence of any characterizing ingredient(s) or
component(s) and/or the need for the user to add any characterizing
ingredient(s) or component(s) when the presence or absence of such
ingredient(s) or component(s) in the food has a material bearing on
price or consumer acceptance or when the labeling or the appearance of
the food may otherwise create an erroneous impression that such
ingredient(s) or component(s) is present when it is not, and consumers
may otherwise be misled about the presence or absence of the
ingredient(s) or component(s) in the food. The following requirements
shall apply unless modified by a specific regulation in this part.
[[Page 33]]
(1) The presence or absence of a characterizing ingredient or
component shall be declared by the words ``containing (or contains) ----
----'' or ``containing (or contains) ----------'' or ``no ----------''
or ``does not contain ----------'', with the blank being filled in with
the common or usual name of the ingredient or component.
(2) The need for the user of a food to add any characterizing
ingredient(s) or component(s) shall be declared by an appropriate
informative statement.
(3) The statement(s) required under paragraph (c) (1) and/or (2) of
this section shall appear following or directly below the part of the
common or usual name of the food required by paragraphs (a) and (b) of
this section, in easily legible boldface print or type in distinct
contrast to other printed or graphic matter, and in a height not less
than the larger of the alternatives established under paragraph (b)(2)
(i) and (ii) of this section.
(d) A common or usual name of a food may be established by common
usage or by establishment of a regulation in this part, in a standard of
identity, or in other regulations in this chapter.
[41 FR 38627, Sept. 10, 1976. Redesignated at 42 FR 14091, Mar. 15,
1977]
Sec. 502.19 Petitions.
(a) The Commissioner of Food and Drugs, either on his own initiative
or on behalf of any interested person who has submitted a petition, may
publish a proposal to issue, amend, or revoke, under this part, a
regulation prescribing a common or usual name for a food, pursuant to
part 10 of this chapter.
(b) If the principal display panel of a food for which a common or
usual name regulation is established is too small to accommodate all
mandatory requirements, the Commissioner may establish by regulation an
acceptable alternative, e.g., a smaller type size. A petition requesting
such a regulation, which would amend the applicable regulation, shall be
submitted pursuant to part 10 of this chapter.
[42 FR 4716, Jan. 25, 1977; 42 FR 10980, Feb. 25, 1977. Redesignated at
42 FR 14091, Mar. 15, 1977, and amended at 42 FR 15675, Mar. 22, 1977;
42 FR 24254, May 13, 1977]
PART 509_UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING
MATERIAL--Table of Contents
Subpart A_General Provisions
Sec.
509.3 Definitions and interpretations.
509.4 Establishment of tolerances, regulatory limits, and action levels.
509.5 Petitions.
509.6 Added poisonous or deleterious substances.
509.7 Unavoidability.
509.15 Use of polychlorinated biphenyls (PCB's) in establishments
manufacturing food-packaging materials.
Subpart B_Tolerances for Unavoidable Poisonous or Deleterious Substances
509.30 Temporary tolerances for polychlorinated biphenyls (PCB's).
Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances
[Reserved]
Subpart D--Naturally Occurring Poisonous or Deleterious Substances
[Reserved]
Authority: 21 U.S.C. 336, 342, 346, 346a, 348, 371.
Source: 42 FR 52821, Sept. 30, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 509.3 Definitions and interpretations.
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) The definitions of terms contained in section 201 of the act are
applicable to such terms when used in this part unless modified in this
section.
(c) A naturally occurring poisonous or deleterious substance is a
poisonous or deleterious substance that is an inherent natural
constituent of a food and is not the result of environmental,
agricultural, industrial, or other contamination.
(d) An added poisonous or deleterious substance is a poisonous or
deleterious substance that is not a naturally occurring poisonous or
deleterious substance. When a naturally occurring poisonous or
deleterious substance is increased to abnormal levels through
[[Page 34]]
mishandling or other intervening acts, it is an added poisonous or
deleterious substance to the extent of such increase.
(e) Food includes pet food, animal feed, and substances migrating to
food from food-contact articles.
Sec. 509.4 Establishment of tolerances, regulatory limits, and action
levels.
(a) When appropriate under the criteria of Sec. 509.6, a tolerance
for an added poisonous or deleterious substance, which may be a food
additive, may be established by regulation in subpart B of this part
under the provisions of section 406 of the act. A tolerance may prohibit
any detectable amount of the substance in food.
(b) When appropriate under the criteria of Sec. 509.6, and under
section 402(a)(1) of the act, a regulatory limit for an added poisonous
or deleterious substance, which may be a food additive, may be
established by regulation in subpart C of this part under the provisions
of sections 402(a)(1) and 701(a) of the act. A regulatory limit may
prohibit any detectable amount of the substance in food. The regulatory
limit established represents the level at which food is adulterated
within the meaning of section 402(a)(1) of the act.
(c)(1) When appropriate under the criteria of Sec. 509.6, an action
level for an added poisonous or deleterious substance, which may be a
food additive, may be established to define a level of contamination at
which a food may be regarded as adulterated.
(2) Whenever an action level is established or changed, a notice
shall be published in the Federal Register as soon as practicable
thereafter. The notice shall call attention to the material supporting
the action level which shall be on file with the Division of Dockets
Management before the notice is published. The notice shall invite
public comment on the action level.
(d) A regulation may be established in subpart D of this part to
identify a food containing a naturally occurring poisonous or
deleterious substance which will be deemed to be adulterated under
section 402(a)(1) of the act. These regulations do not constitute a
complete list of such foods.
[42 FR 52821, Sept. 30, 1977, as amended at 55 FR 20786, May 21, 1990]
Sec. 509.5 Petitions.
The Commissioner of Food and Drugs, either on his own initiative or
on behalf of any interested person who has submitted a petition, may
issue a proposal to establish, revoke, or amend a regulation under this
part. Any such petition shall include an adequate factual basis to
support the petition, shall be in the form set forth in Sec. 10.30 of
this chapter, and will be published in the Federal Register for comment
if it contains reasonable grounds for the proposed regulation.
[42 FR 52821, Sept. 30, 1977, as amended at 54 FR 18280, Apr. 28, 1989]
Sec. 509.6 Added poisonous or deleterious substances.
(a) Use of an added poisonous or deleterious substance, other than a
pesticide chemical, that is also a food additive will be controlled by a
regulation issued under section 409 of the act when possible. When such
a use cannot be approved under the criteria of section 409 of the act,
or when the added poisonous or deleterious substance is not a food
additive, a tolerance, regulatory limit, or action level may be
established pursuant to the criteria in paragraphs (b), (c), or (d) of
this section. Residues resulting from the use of an added poisonous or
deleterious substance that is also a pesticide chemical will ordinarily
be controlled by a tolerance established in a regulation issued under
sections 406, 408, or 409 of the act by the U.S. Environmental
Protection Agency (EPA). When such a regulation has not been issued, an
action level for an added poisonous or deleterious substance that is
also a pesticide chemical may be established by the Food and Drug
Administration. The Food and Drug Administration will request EPA to
recommend such an action level pursuant to the criteria established in
paragraph (d) of this section.
(b) A tolerance for an added poisonous or deleterious substance in
any food may be established when the following criteria are met:
[[Page 35]]
(1) The substance cannot be avoided by good manufacturing practice.
(2) The tolerance established is sufficient for the protection of
the public health, taking into account the extent of which the presence
of the substance cannot be avoided and the other ways in which the
consumer may be affected by the same or related poisonous or deleterious
substances.
(3) No technological or other changes are foreseeable in the near
future that might affect the appropriateness of the tolerance
established. Examples of changes that might affect the appropriateness
of the tolerance include anticipated improvements in good manufacturing
practice that would change the extent to which use of the substance is
unavoidable and anticipated studies expected to provide significant new
toxicological or use data.
(c) A regulatory limit for an added poisonous or deleterious
substance in any food may be established when each of the following
criteria is met:
(1) The substance cannot be avoided by current good manufacturing
practices.
(2) There is no tolerance established for the substance in the
particular food under sections 406, 408, or 409 of the act.
(3) There is insufficient information by which a tolerance may be
established for the substance under section 406 of the act or
technological changes appear reasonably possible that may affect the
appropriateness of a tolerance. The regulatory limit established
represents the level at which food is adulterated within the meaning of
section 402(a)(1) of the act.
(d) An action level for an added poisonous or deleterious substance
in any food may be established when the criteria in paragraph (b) of
this section are met, except that technological or other changes that
might affect the appropriateness of the tolerance are foreseeable in the
near future. An action level for an added poisonous or deleterious
substance in any food may be established at a level at which the Food
and Drug Administration may regard the food as adulterated within the
meaning of section 402(a)(1) of the act, without regard to the criteria
in paragraph (b) of this section or in section 406 of the act. An action
level will be withdrawn when a tolerance or regulatory limit for the
same substance and use has been established.
(e) Tolerances will be established under authority appropriate for
action levels (sections 306, 402(a), and 701(a) of the act, together
with section 408 or 409 of the act, if appropriate) as well as under
authority appropriate for tolerances (sections 406 and 701 of the act).
In the event the effectiveness of a tolerance is stayed pursuant to
section 701(e)(2) of the act by the filing of an objection, the order
establishing the tolerance shall be deemed to be an order establishing
an action level until final action is taken upon such objection.
[42 FR 52821, Sept. 30, 1977, as amended at 55 FR 20786, May 21, 1990]
Sec. 509.7 Unavoidability.
(a) Tolerances and action levels in this part are established at
levels based on the unavoidability of the poisonous or deleterious
substance concerned and do not establish a permissible level of
contamination where it is avoidable.
(b) Compliance with tolerances, regulatory limits, and action levels
does not excuse failure to observe either the requirement in section
402(a)(4) of the act that food may not be prepared, packed, or held
under insanitary conditions or the other requirements in this chapter
that food manufacturers must observe current good manufacturing
practices. Evidence obtained through factory inspection or otherwise
indicating such a violation renders the food unlawful, even though the
amounts of poisonous or deleterious substances are lower than the
currently established tolerances, regulatory limits, or action levels.
The manufacturer of food must at all times utilize quality control
procedures which will reduce contamination to the lowest level currently
feasible.
[42 FR 52821, Sept. 30, 1977, as amended at 55 FR 20786, May 21, 1990]
Sec. 509.15 Use of polychlorinated biphenyls (PCB's) in establishments
manufacturing food-packaging materials.
(a) Polychlorinated biphenyls (PCB's) represent a class of toxic
industrial chemicals manufactured and sold under
[[Page 36]]
a variety of trade names, including: Aroclor (United States); Phenoclor
(France); Colphen (Germany); and Kanaclor (Japan). PCB's are highly
stable, heat resistant, and nonflammable chemicals. Industrial uses of
PCB's include, or did include in the past, their use as electrical
transformer and capacitor fluids, heat transfer fluids, hydraulic
fluids, and plasticizers, and in formulations of lubricants, coatings,
and inks. Their unique physical and chemical properties and widespread,
uncontrolled industrial applications have caused PCB's to be a
persistent and ubiquitous contaminant in the environment, causing the
contamination of certain foods. In addition, incidents have occurred in
which PCB's have directly contaminated animal feeds as a result of
industrial accidents (leakage or spillage of PCB fluids from plant
equipment). These accidents in turn caused the contamination of food
products intended for human consumption (meat, milk and eggs).
Investigations by the Food and Drug Administration have revealed that a
significant percentage of paper food-packaging material contains PCB's
which can migrate to the packaged food. The origin of PCB's in such
material is not fully understood. Reclaimed fibers containing carbonless
copy paper (contains 3 to 5 percent PCB's) have been identified as a
primary source of PCB's in paper products. Some virgin paper products
have also been found to contain PCB's, the source of which is generally
attributed to direct contamination from industrial accidents from the
use of PCB-containing equipment and machinery in food-packaging
manufacturing establishments. Since PCB's are toxic chemicals, the PCB
contamination of food-packaging materials as a result of industrial
accidents, which can cause the PCB contamination of food, represents a
hazard to public health. It is therefore necessary to place certain
restrictions on the industrial uses of PCB's in establishments
manufacturing food-packaging materials.
(b) The following special provisions are necessary to preclude the
accidental PCB contamination of food-packaging materials:
(1) New equipment or machinery for manufacturing food-packaging
materials shall not contain or use PCB's.
(2) On or before September 4, 1973, the management of establishments
manufacturing food-packaging materials shall:
(i) Have the heat exchange fluid used in existing equipment for
manufacturing food-packaging materials sampled and tested to determine
whether it contains PCB's or verify the absence of PCB's in such
formulations by other appropriate means. On or before Sept. 4, 1973, any
such fluid formulated with PCB's must to the fullest extent possible
commensurate with current good manufacturing practices be replaced with
a heat exchange fluid that does not contain PCB's.
(ii) Eliminate to the fullest extent possible commensurate with
current good manufacturing practices from the establishment any other
PCB-containing equipment, machinery and materials wherever there is a
reasonable expectation that such articles could cause food-packaging
materials to become contaminated with PCB's either as a result of normal
use or as a result of accident, breakage, or other mishap.
(iii) The toxicity and other characteristics of fluids selected as
PCB replacements must be adequately determined so that the least
potentially hazardous replacement is used. In making this determination
with respect to a given fluid, consideration should be given to (a) its
toxicity; (b) the maximum quantity that could be spilled onto a given
quantity of food before it would be noticed, taking into account its
color and odor; (c) possible signaling devices in the equipment to
indicate a loss of fluid, etc.; and (d) its environmental stability and
tendency to survive and be concentrated through the food chain. The
judgment as to whether a replacement fluid is sufficiently non-hazardous
is to be made on an individual installation and operation basis.
(c) The provisions of this section do not apply to electrical
transformers and condensers containing PCB's in sealed containers.
[[Page 37]]
Subpart B_Tolerances for Unavoidable Poisonous or Deleterious Substances
Sec. 509.30 Temporary tolerances for polychlorinated biphenyls (PCB's).
(a) Polychlorinated biphenyls (PCB's) are toxic, industrial
chemicals. Because of their widespread, uncontrolled industrial
applications, PCB's have become a persistent and ubiquitous contaminant
in the environment. As a result, certain foods and animal feeds,
principally those of animal and marine origin, contain PCB's as
unavoidable, environmental contaminants. PCB's are transmitted to the
food portion (meat, milk, and eggs) of food producing animals ingesting
PCB contaminated animal feed. In addition, a significant percentage of
paper food-packaging materials contain PCB's which may migrate to the
packaged food. The source of PCB's in paper food-packaging materials is
primarily of certain types of carbonless copy paper (containing 3 to 5
percent PCB's) in waste paper stocks used for manufacturing recycled
paper. Therefore, temporary tolerances for residues of PCB's as
unavoidable environmental or industrial contaminants are established for
a sufficient period of time following the effective date of this
paragraph to permit the elimination of such contaminants at the earliest
practicable time. For the purposes of this paragraph, the term
polychlorinated biphenyls (PCB's) is applicable to mixtures of
chlorinated biphenyl compounds, irrespective of which mixture of PCB's
is present as the residue. The temporary tolerances for residues of
PCB's are as follows:
(1) 0.2 part per million in finished animal feed for food-producing
animals (except the following finished animal feeds: feed concentrates,
feed supplements, and feed premixes).
(2) 2 parts per million in animal feed components of animal origin,
including fishmeal and other by-products of marine origin and in
finished animal feed concentrates, supplements, and premixes intended
for food-producing animals.
(3) 10 parts per million in paper food-packaging material intended
for or used with finished animal feed and any components intended for
animal feeds. The tolerance shall not apply to paper food-packaging
material separated from the food therein by a functional barrier which
is impermeable to migration of PCB's.
(b) A compilation entitled ``Analytical Methodology for
Polychlorinated Biphenyls, February 1973'' for determining compliance
with the tolerances established in this section is available from the
Division of Dockets Management, Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
[42 FR 52821, Sept. 30, 1977, as amended at 46 FR 8460, Jan. 27, 1981;
59 FR 14365, Mar. 28, 1994; 68 FR 24879, May 9, 2003]
Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances
[Reserved]
Subpart D--Naturally Occurring Poisonous or Deleterious Substances
[Reserved]
PART 510_NEW ANIMAL DRUGS--Table of Contents
Subpart A_General Provisions
Sec.
510.3 Definitions and interpretations.
510.4 Biologics; products subject to license control.
510.7 Consignees of new animal drugs for use in the manufacture of
animal feed.
510.95 [Reserved]
Subpart B_Specific Administrative Rulings and Decisions
510.105 Labeling of drugs for use in milk-producing animals.
510.106 Labeling of antibiotic and antibiotic-containing drugs intended
for use in milk-producing animals.
510.110 Antibiotics used in food-producing animals.
510.112 Antibiotics used in veterinary medicine and for nonmedical
purposes; required data.
Subpart C [Reserved]
Subpart D_Records and Reports
510.301 Records and reports concerning experience with animal feeds
bearing or containing new animal drugs for which an approved
medicated feed mill license application is in effect.
[[Page 38]]
510.305 Maintenance of copies of approved medicated feed mill licenses
to manufacture animal feed bearing or containing new animal
drugs.
Subpart E_Requirements for Specific New Animal Drugs
510.410 Corticosteroids for oral, injectable, and ophthalmic use in
animals; warnings and labeling requirements.
510.440 Injectable iron preparations.
510.455 Requirements for free-choice medicated feeds.
Subpart F_Animal Use Exemptions From Certification and Labeling
Requirements
510.515 Animal feeds bearing or containing new animal drugs subject to
the provisions of section 512(n) of the act.
Subpart G_Sponsors of Approved Applications
510.600 Names, addresses, and drug labeler codes of sponsors of approved
applications.
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Source: 40 FR 13807, Mar. 27, 1975, unless otherwise noted.
Subpart A_General Provisions
Sec. 510.3 Definitions and interpretations.
As used in this part:
(a) The term act means the Federal Food, Drug, and Cosmetic Act, as
amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C.
321-392).
(b) Department means the Department of Health and Human Services.
(c) Secretary means the Secretary of Health and Human Services.
(d) Commissioner means the Commissioner of Food and Drugs.
(e) Person means individuals, partnerships, corporations, and
associations.
(f) The definitions and interpretations of terms contained in
section 201 of the act shall be applicable to such terms when used in
the regulations in this part.
(g) The term new animal drug means any drug intended for use for
animals other than man, including any drug intended for use in animal
feed but not including such animal feed:
(1) The composition of which is such that such drug is not generally
recognized, among experts qualified by scientific training and
experience to evaluate the safety and effectiveness of animal drugs, as
safe and effective for use under the conditions prescribed, recommended,
or suggested in the labeling thereof; except that such a drug not so
recognized shall not be deemed to be a new animal drug if at any time
prior to June 25, 1938, it was subject to the Food and Drug Act of June
30, 1906, as amended, and if at such time its labeling contained the
same representations concerning the conditions of its use; or
(2) The composition of which is such that such drug, as a result of
investigations to determine its safety and effectiveness for use under
such conditions, has become so recognized but which has not, otherwise
than in such investigations, been used to a material extent or for a
material time under such conditions.
(h) The term animal feed means an article which is intended for use
for food for animals other than man and which is intended for use as a
substantial source of nutrients in the diet of the animal, and is not
limited to a mixture intended to be the sole ration of the animal.
(i) The newness of an animal drug, including a new animal drug
intended for use in or on animal feed, may arise by reason of: (1) The
newness for its intended drug use of any substance of which the drug is
comprised, in whole or in part, whether it be an active substance or a
menstruum, excipient, carrier, coating, or other component; (2) the
newness for its intended drug use of a combination of two or more
substances, none of which is itself a new animal drug; (3) the newness
for its intended drug use of the proportion of a substance in a
combination, even though such combination containing such substance in
other proportion is not a new animal drug; (4) the newness for its
intended drug use in a different species of animal; (5) the newness of
its intended drug use in diagnosing, curing, mitigating, treating, or
preventing a disease, or to affect a structure or function of the animal
body, even though such drug is not a new animal drug when used in
another disease or to affect another structure or function of
[[Page 39]]
the body; or (6) the newness of a dosage, or method or duration of
administration or application, or any other condition of use prescribed,
recommended, or suggested in the labeling of such drug, even though such
drug or animal feed containing such drug when used in another dosage, or
another method or duration of administration or application, or
different condition, is not a new animal drug.
(j) Animals used only for laboratory research and laboratory
research animals mean individual animals or groups of animals intended
for use and used solely for laboratory research purposes, regardless of
species, and does not include animals intended to be used for any food
purposes or animals intended to be kept as livestock.
(k) The term sponsor means the person responsible for an
investigation of a new animal drug, including responsibility for
compliance with applicable provisions of the act and regulations. The
sponsor may be an individual, partnership, corporation, or Government
agency or may be a manufacturer, scientific institution, or an
investigator regularly and lawfully engaged in the investigation of new
animal drugs.
[40 FR 13807, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 54
FR 22741, May 26, 1989; 64 FR 69190, Dec. 10, 1999]
Sec. 510.4 Biologics; products subject to license control.
An animal drug produced and distributed in full conformance with the
animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21
U.S.C. 151 et seq. ) and any regulations issued thereunder shall not be
deemed to be subject to section 512 of the Federal Food, Drug, and
Cosmetic Act.
Sec. 510.7 Consignees of new animal drugs for use in the manufacture
of animal feed.
(a) A new animal drug intended for use in the manufacture of animal
feed shall be deemed to be unsafe unless at the time of its removal from
the establishment of a manufacturer, packer, or distributor of such
drug, such manufacturer, packer, or distributor has an unrevoked written
statement from the consignee of such drug, or a notice from the
Secretary, to the effect that with respect to the use of such drug in
animal feed the consignee:
(1) Holds a license issued under Sec. 515.20 of this chapter; or
(2) Will, if the consignee is not the user of the drug, ship such
drug only to a holder of an approved application under Sec. 515.10 of
this chapter.
(b) The requirements of paragraph (a) of this section do not apply:
(1) Where such drugs are intended for export and/or
(2) When the use of such drug in the manufacture of a finished feed
has been exempted from the requirements of section 512(m) of the act
under the conditions specified by regulations published in part 558 of
this chapter.
[40 FR 13807, Mar. 27, 1975, as amended at 64 FR 63203, Nov. 19, 1999]
Sec. 510.95 [Reserved]
Subpart B_Specific Administrative Rulings and Decisions
Sec. 510.105 Labeling of drugs for use in milk-producing animals.
(a) Part 526 of this chapter provides for new animal drugs intended
for intramammary use in animals and includes conditions of use intended
to prevent the contamination of milk from the use of such drugs.
(b) Preparations containing antibiotics and other potent drugs
labeled with directions for use in milk-producing animals will be
misbranded under section 502(f)(2) of the act unless their labeling
bears appropriate warnings and directions for use to avoid adulteration
of milk under section 402(a)(2)(c)(ii) of the act.
(c) It is the position of the Food and Drug Administration that the
labeling for such preparations should bear a clear warning that either:
(1) The article should not be administered to animals producing
milk, since to do so would result in contamination of the milk; or
(2) The label should bear the following statement: ``Warning: Milk
that has been taken from animals during treatment and for ---- hours
after the latest treatment must not be used for food'', the blank being
filled in with the figure that the manufacturer has
[[Page 40]]
determined by appropriate investigation is needed to insure that the
milk will not carry violative residues resulting from use of the
preparation. If the use of the preparation as recommended does not
result in contamination of the milk, neither of the above warning
statements is required.
[40 FR 13807, Mar. 27, 1975, as amended at 63 FR 32980, June 17, 1998;
64 FR 51241, Sept. 22, 1999]
Sec. 510.106 Labeling of antibiotic and antibiotic-containing drugs
intended for use in milk-producing animals.
Whenever the labeling of an antibiotic drug included in the
regulations in this chapter suggests or recommends its use in milk-
producing animals, the label of such drugs shall bear either the
statement ``Warning: Not for use in animals producing milk, since this
use will result in contamination of the milk'' or the statement
``Warning: Milk that has been taken from animals during treatment and
for ----hours after the latest treatment must not be used for food'',
the blank being filled in with the figure that the Commissioner has
authorized the manufacturer of the drug to use. The Commissioner shall
determine what such figures shall be from information submitted by the
manufacturer and which the Commissioner considers is adequate to prove
that period of time after the latest treatment that the milk from
treated animals will contain no violative residues from use of the
preparation. If the Commissioner determines from the information
submitted that the use of the antibiotic drug as recommended does not
result in its appearance in the milk, the Commissioner may exempt the
drug from bearing either of the above warning statements.
[63 FR 32980, June 17, 1998]
Sec. 510.110 Antibiotics used in food-producing animals.
(a) The Food and Drug Administration in the interest of fulfilling
its responsibilities with regard to protection of the public health has
requested an evaluation of the public health aspects of the use of
antibiotics in veterinary medical and nonmedical uses. There is
particular concern with regard to the potential hazards associated with
the extensive use of antibiotics administered to food-producing animals.
Accordingly, an ad hoc committee on the Veterinary Medical and
Nonmedical Uses of Antibiotics was established by the Food and Drug
Administration to study and advise the Commissioner of Food and Drugs on
the uses of antibiotics in veterinary medicine and for various
nonmedical purposes as such uses may affect the enforcement of the
Federal Food, Drug, and Cosmetic Act with respect to their safety and
effectiveness.
(b) Based upon an evaluation of the conclusions of said Committee
and other relevant material, Sec. 510.112 was published in the Federal
Register of August 23, 1966 (31 FR 11141), asking sponsors of drugs
containing any antibiotic intended for use in food-producing animals to
submit data to establish whether such antibiotic and its metabolites are
present as residues in edible tissues, milk, and eggs from treated
animals. The data on the residues of antibiotics in milk from
intramammary infusion preparations were requested within 60 days and the
data on all other products were requested within 180 days following the
date of publication of Sec. 510.112 in the Federal Register.
(c) An evaluation of the data now available shows that use of many
antibiotic preparations cause residues in edible products of treated
animals for varying and, in some cases, for long periods of time
following the last administration. Because of the accumulation of new
information with regard to the development of resistance of bacteria to
antibiotics, the ability of bacteria to transfer this resistance, and
the development of sensitivity to antibiotics in humans, unauthorized
and unsafe residues of antibiotics cannot be permitted in food obtained
from treated animals.
(d) Based on evaluation of information available, including the
conclusions of the aforementioned ad hoc Committee, the Commissioner
concludes that antibiotic preparations intended for use in food-
producing animals, other than topical and ophthalmic preparations, are
not generally recognized among qualified experts as having been shown to
be safe for their intended use(s) within the meaning of
[[Page 41]]
section 201(s) of the Federal Food, Drug, and Cosmetic Act.
(e) Therefore, all exemptions from the provisions of section 409 of
the act for use of antibiotics in food-producing animals based on
sanctions or approvals granted prior to enactment of the Food Additives
Amendment of 1958 (Pub. L. 85-929; 72 Stat. 1784) will be revoked and
the uses which are concluded to be safe will be covered by food additive
regulations. On those products for which there are inadequate residue
data, actions will be initiated to withdraw approval of new-drug
applications under the provisions of section 505 of the act. Antibiotic
preparations, other than those for topical and ophthalmic application in
food-producing animals, which are not covered by food additive
regulations will be subject to regulatory action within 180 days after
publication of the forthcoming revocation order.
(f) Because of the variation in the period of time that antibiotic
residues may remain in edible products from treated animals, all
injectable, intramammary infusion, intrauterine, and oral preparations,
including medicated premixes intended for use in food-producing animals,
are deemed to be new drugs as well as food additives.
[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989;
64 FR 403, Jan. 5, 1999]
Sec. 510.112 Antibiotics used in veterinary medicine and for nonmedical
purposes; required data.
(a) An ad hoc committee, Committee on the Veterinary Medical and
Nonmedical Uses of Antibiotics, was formed by the Food and Drug
Administration to study, and advise the Commissioner on, the use of
antibiotics in veterinary medicine and for various nonmedical purposes
as such uses may affect the enforcement of the Federal Food, Drug, and
Cosmetic Act with respect to the safety and effectiveness of such
substances. A copy of the report may be obtained from the Food and Drug
Administration, Office of Public Affairs, Room 15-05, Parklawn Building,
5600 Fishers Lane, Rockville, MD 20857.
(b) On the basis of the report of the Committee and other
information, sponsors of drugs containing any antibiotic intended for
use in food-producing animals shall submit data for determining whether
or not such antibiotics and their metabolites are present as residues in
edible tissues, milk, and eggs from treated animals; however, in the
case of a drug for which such data have already been submitted and for
which a regulation has been promulgated under section 409 of the act,
only such data as has been accumulated since the issuance of the
regulation need be submitted.
(c) The required data shall be submitted within 180 days of the date
of publication of this section in the Federal Register; except that in
the case of data on intramammary infusion preparations the data shall be
submitted within 60 days of such publication. Data demonstrating the
absence in milk of residues of intramammary infusion preparations when
used as directed in their labeling are needed within the 60-day period
because of the importance of milk in the human diet.
(d) Regulatory proceedings including revocation of prior sanctions,
or actions to suspend or amend new drug or antibiotic approvals granted
prior to passage of the Food Additives Amendment of 1958 (72 Stat.
1784), may be initiated with regard to the continued marketing of any
antibiotic preparation on which the required information is not
submitted within the period of time prescribed by paragraph (c) of this
section.
(e) Questions relating to the acceptability of proposed research
protocols and assay methods for determining the amount of antibiotic
residues in food should be directed to the Director, Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855.
[40 FR 13807, Mar. 27, 1975, as amended at 46 FR 8460, Jan. 27, 1981; 54
FR 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992]
Subpart C [Reserved]
[[Page 42]]
Subpart D_Records and Reports
Sec. 510.301 Records and reports concerning experience with animal
feeds bearing or containing new animal drugs for which an approved
medicated feed mill
license application is in effect.
Records and reports of clinical and other experience with the new
animal drug will be maintained and reported, appropriately identified
with the new animal drug application(s) to which they relate, to the
Center for Veterinary Medicine in duplicate in accordance with the
following:
(a) Immediately upon receipt by the applicant, complete records or
reports covering information of the following kinds:
(1) Information concerning any mixup in the new animal drug or its
labeling with another article.
(2) Information concerning any bacteriological, or any significant
chemical, physical, or other change or deterioration in the drug, or any
failure of one or more distributed batches of the drug to meet the
specifications established for it in the new animal drug application.
(b) As soon as possible, and in any event within 15 working days of
its receipt by the applicant, complete records or reports concerning any
information of the following kinds:
(1) Information concerning any unexpected side effect, injury,
toxicity, or sensitivity reaction or any unexpected incidence or
severity thereof associated with clinical uses, studies, investigations,
or tests, whether or not determined to be attributable to the new animal
drug, except that this requirement shall not apply to the submission of
information described in a written communication to the applicant from
the Food and Drug Administration as types of information that may be
submitted at other designated intervals. Unexpected as used in this
paragraph refers to conditions or developments not previously submitted
as part of the new animal drug application or not encountered during
clinical trials of the drug, or conditions or developments occurring at
a rate higher than shown by information previously submitted as part of
the new animal drug application or at a rate higher than encountered
during such clinical trials.
(2) Information concerning any unusual failure of the new animal
drug to exhibit its expected pharmacological activity.
[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989]
Sec. 510.305 Maintenance of copies of approved medicated feed mill
licenses to manufacture animal feed bearing or containing new animal drugs.
Each applicant shall maintain in a single accessible location:
(a) A copy of the approved medicated feed mill license (Form FDA
3448) on the premises of the manufacturing establishment; and
(b) Approved labeling for each Type B and/or Type C feed being
manufactured on the premises of the manufacturing establishment or the
facility where the feed labels are generated.
[64 FR 63203, Nov. 19, 1999]
Subpart E_Requirements for Specific New Animal Drugs
Sec. 510.410 Corticosteroids for oral, injectable, and ophthalmic
use in animals; warnings and labeling requirements.
(a) The Food and Drug Administration has received reports of side
effects associated with the oral, injectable, and ophthalmic use of
corticosteroid animal drugs. The use of these drugs administered orally
or by injection has resulted in premature parturition when administered
during the last trimester of pregnancy. Premature parturition may be
followed by dystocia, fetal death, retained placenta, and metritis.
Additionally, corticosteroids used in dogs, rabbits, and rodents during
pregnancy have produced cleft palate in offspring. Use in dogs has
resulted in other congenital anomalies, including deformed forelegs,
phocomelia, and anasarca. Drugs subject to this section are required to
carry the veterinary prescription legend and are subject to the labeling
requirements of Sec. 201.105 of this chapter.
(b) In view of these potentially serious side effects, the Food and
Drug Administration has concluded that the labeling on or within
packaged
[[Page 43]]
corticosteroid-containing preparations intended for animal use shall
bear conspicuously the following warning statement:
Warning: Clinical and experimental data have demonstrated that
corticosteroids administered orally or by injection to animals may
induce the first stage of parturition if used during the last trimester
of pregnancy and may precipitate premature parturition followed by
dystocia, fetal death, retained placenta, and metritis.
Additionally, corticosteroids administered to dogs, rabbits, and
rodents during pregnancy have resulted in cleft palate in offspring.
Corticosteroids administered to dogs during pregnancy have also resulted
in other congenital anomalies, including deformed forelegs, phocomelia,
and anasarca.
[49 FR 48535, Dec. 13, 1984]
Sec. 510.440 Injectable iron preparations.
There has been an increasing interest in the use of injectable iron
compounds for the prevention or treatment of iron-deficiency anemia in
animals. Although some such preparations have been shown to be safe,
such articles are regarded as new animal drugs within the meaning of the
Federal Food, Drug, and Cosmetic Act. Accordingly, an approved new
animal drug application is required prior to the marketing of such
preparations within the jurisdiction of the act. In addition to the need
for demonstrating the safety of such articles, the labeling of such
preparations should not only recommend appropriate dosages of iron but
also declare the amount (in milligrams) of available iron (Fe) per
milliliter of the subject product.
Sec. 510.455 Requirements for free-choice medicated feeds.
(a) What is free-choice medicated feed? For the purpose of this
part, free-choice medicated feed is medicated feed that is placed in
feeding or grazing areas and is not intended to be consumed fully at a
single feeding or to constitute the entire diet of the animal. Free-
choice feeds include, but are not limited to, medicated blocks
(agglomerated feed compressed or rendered into a solid mass and cohesive
enough to hold its form), mineral mixes, and liquid feed tank
supplements (``lick tank'' supplements) containing one or more new
animal drugs. The manufacture of medicated free-choice feeds is subject
to the current good manufacturing practice regulations in part 225 of
this chapter for medicated feeds.
(b) What types of approvals are required for new animal drugs
intended for use in free-choice feed? New animal drugs intended for use
in free-choice feed must be approved for such use under section 512 of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(b)),
as:
(1) An original new animal drug application (NADA),
(2) A supplemental NADA, or
(3) An abbreviated NADA.
(c) What are the approval requirements for new animal drugs intended
for use in free-choice feed? (1) An approval under section 512 of the
act is required for any new animal drug intended for use in a free-
choice feed.
(2) An approved NADA for a Type A medicated article intended for use
in free-choice feed must contain the following information:
(i) Data, or reference to data in a master file (MF), showing that
the target animal consumes the new animal drug in the Type C free-choice
feed in an amount that is safe and effective (consumption/effectiveness
data); and
(ii) Data, or reference to data in a MF, showing the relevant ranges
of conditions under which the drug will be chemically and physically
stable in the Type C free-choice feed under field conditions.
(d) How are consumption/effectiveness and/or stability data to be
submitted? The data must be submitted as follows:
(1) Directly in the NADA, by a sponsor; and/or
(2) To an MF that a sponsor may then reference in its NADA with
written consent of the MF holder.
(e) What will be stated in the published approval for a new animal
drug intended for use in free-choice feed? The approval of a new animal
drug intended for use in free-choice feed, as published in this
subchapter, will include:
(1) The formula and/or specifications of the free-choice medicated
feed, where the owner of this information requests such publication, or
[[Page 44]]
(2) A statement that the approval has been granted for a proprietary
formula and/or specifications.
(f) When is a medicated feed mill license required for the
manufacture of a free-choice medicated feed? An approved medicated feed
mill license is required for the manufacture of the following types of
feeds:
(1) All free-choice medicated feeds that contain a Category II drug,
and
(2) Free-choice medicated feeds that contain a Category I drug and
use a proprietary formula and/or specifications.
[69 FR 30197, May 27, 2004]
Subpart F_Animal Use Exemptions From Certification and Labeling
Requirements
Sec. 510.515 Animal feeds bearing or containing new animal drugs
subject to the provisions of section 512(n) of the act.
Animal feeds that bear or contain penicillin, chlortetracycline,
feed grade zinc bacitracin, and bacitracin methylene disalicylate, with
or without added suitable nutritive ingredients are exempt from the
certification requirements of section 512 of the act provided they are
the subject of and in compliance with regulations for their use in this
subchapter E, part 558 of this chapter, or any one of the paragraphs of
this section:
(a) Where indicated in paragraph (b) of this section it is
manufactured with or without one, but only one, of the following
ingredients in a quantity, by weight of feed, as hereinafter indicated:
(1) Arsanilic acid: Not less than 0.005 percent and not more than
0.01 percent.
(2) Sodium arsanilate: Not less than 0.005 percent and not more than
0.01 percent.
(3) 3-Nitro-4-hydroxyphenylarsonic acid: Not less than 0.0025
percent and not more than 0.0075 percent except in chicken or turkey
feed which shall contain not less than 0.0025 percent and not more than
0.005 percent.
(b) It is intended for use in any one of the following conditions
set forth in this paragraph:
(1) It is intended for use solely in the treatment of chronic
respiratory disease (air-sac infection), infectious sinusitis, and blue
comb (nonspecific infectious enteritis) in poultry and/or bacterial
swine enteritis; its labeling bears adequate directions and warnings for
such use; and it contains, per ton of feed, the equivalent of 100 grams
of penicillin. When intended for uses specified in this paragraph, it
may also contain, in the amount specified, one, but only one, of the
ingredients prescribed by paragraph (a) of this section.
(2) It is intended for use solely in the treatment of chronic
respiratory disease (air-sac infection) and infectious sinusitis in
poultry; its labeling bears adequate directions and warnings for such
use; and it contains not less than 0.1 percent para-aminobenzoic acid or
the sodium or potassium salt or para-aminobenzoic acid.
(3)-(29) [Reserved]
(c) It is intended for use as follows:
----------------------------------------------------------------------------------------------------------------
Product Species Use levels Indications for use
----------------------------------------------------------------------------------------------------------------
1. Nicarbazin................. Chickens................ 0.01 to 0.02 percent..... For use in the prevention
......do................ 2.4 to 50 g/ton.......... of outbreaks of
coccidiosis in poultry
flocks; growth promotion
and feed efficiency.
2. Nicarbazin................. ......do................ 0.01 to 0.02 percent..... Do.
Bacitracin methylene ......do................ 4 to 50 g/ton............
disalicylate.
3. Nicarbazin................. ......do................ 0.01 to 0.02 percent..... For use as an aid in the
prevention of coccidiosis
in poultry flocks; growth
promotion and feed
efficiency; improving
pigmentation.
Bacitracin methylene ......do................ 4 to 50 g/ton............
disalicylate.
3-Nitro-4- ......do................ 0.0025 to 0.005 percent..
hydroxyphenylarsonic acid.
4. Nicarbazin................. ......do................ 0.01 to 0.02 percent..... Do.
Procaine penicillin......... ......do................ 2.4 to 50 g/ton..........
3-Nitro-4- ......do................ 0.0025 to 0.005 percent..
hydroxyphenylarsonic acid.
[[Page 45]]
5. Chlortetracycline.......... Swine................... 10 to 50 g/ton........... Enhancement of growth and
feed efficiency.
Arsanilic acid.............. ......do................ 0.005 to 0.01 percent....
----------------------------------------------------------------------------------------------------------------
[41 FR 8299, Feb. 25, 1976, as amended at 41 FR 11011, Mar. 15, 1976; 42
FR 18614, Apr. 8, 1977; 47 FR 42102, Sept. 24, 1982; 47 FR 51563, Nov.
16, 1982; 56 FR 41912, Aug. 23, 1991; 58 FR 30119, May 26, 1993; 61 FR
35950, July 9, 1996]
Subpart G_Sponsors of Approved Applications
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
(a) Section 512(i) of the act requires publication of names and
addresses of sponsors of approved applications for new animal drugs.
(b) In this section each name and address is identified by a
numerical drug labeler code. The labeler codes identify the sponsors of
the new animal drug applications associated with the regulations
published pursuant to section 512(i) of the act. The codes appear in the
appropriate regulations and serve as a reference to the names and
addresses listed in this section. The drug labeler code is established
pursuant to section 510 of the act.
(c) The names, addresses, and drug labeler codes of sponsors of
approved new animal drug applications are as follows:
(1) Alphabetical Listing of Sponsors
------------------------------------------------------------------------
Drug
Firm name and address labeler
code
------------------------------------------------------------------------
Abbott Laboratories, North Chicago, IL 60064................ 000074
ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, 021930
IL 62305-3115..............................................
ADM Animal Health & Nutrition Division, 1000 North 30th St., 017519
Box 1C, Quincy, IL 62305-3115..............................
Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464.............. 024174
Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503 057561
Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112....... 017762
Akzo Nobel Surface Chemistry AB, Box 851, S-44485 063765
Stenungsund, Sweden........................................
Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson, AZ 064146
85712......................................................
Alpharma Inc., One Executive Drive, Fort Lee, NJ 07024...... 046573
Alstoe, Ltd., Animal Health, Pera Innovation Park, 062408
Nottingham Rd., Melton Mowbray, Leicestershire, England
LE13 0PB...................................................
Altana Inc., 60 Baylis Rd., Melville, NY 11747.............. 025463
American Pharmaceuticals Partners, Inc., 2045 North Cornell 063323
Ave., Melrose Park, IL 60160...............................
Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 060865
01801......................................................
Animal Health Pharmaceuticals, LLC, 1805 Oak Ridge Circle, 068718
suite 101, St. Joseph, MO 64506............................
Argent Laboratories, 8702 152d Ave. NE., Redmond, WA 98052.. 051212
Ausa International, Inc., Rt. 8, P.O. Box 324-12, Tyler, TX 059521
75703......................................................
Baxter Healthcare Corp., 95 Spring St., New Providence, NJ 010019
07974......................................................
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, 000859
Shawnee Mission, KS 66201..................................
Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar 062794
Land, TX 77478.............................................
Biocraft Laboratories, Inc., 92 Route 46, Elmwood Park, NJ 000332
07407......................................................
Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 064847
30601......................................................
Bioproducts, Inc., 320 Springside Dr., Suite 300, Fairlawn, 051359
OH 44333-2435..............................................
Biopure Corp., 11 Hurley St., Cambridge, MA 02141........... 063075
BioScience Division of Milk Specialties Co., 1902 Tennyson 032761
Lane, Madison, WI 53704....................................
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt 000010
Highway, St. Joseph, MO 64506-2002.........................
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, 061651
County Galway, Ireland.....................................
Church & Dwight Co., Inc., 469 North Harrison St., 010237
Princeton, NJ 08543-5297...................................
ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 021091
68105......................................................
Contemporary Products, Inc., 3788 Elm Springs Rd., 055462
Springdale, AR 72764-6067..................................
Cooperative Research Farms, Box 69, Charlotteville, NY 12036 051267
Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 061623
24, Ireland................................................
Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 046987
50501......................................................
Custom Feed Services Corp., 2100 N. 13th St., Norfolk, NE 017473
68701......................................................
ECO LLC, 8209 Hollister Ave., Las Vegas, NV 89131........... 066916
Elanco Animal Health, A Division of Eli Lilly & Co., Lilly 000986
Corporate Center, Indianapolis, IN 46285...................
Endo Pharmaceuticals, Inc., 100 Painters Dr., Chadds Ford, 060951
PA 19317...................................................
Eon Labs Manufacturing, Inc. 227-15 North Conduit Ave., 000185
Laurelton, NY 11413........................................
Evsco Pharmaceuticals, An Affiliate of IGI, Inc., Box 209, 017030
Harding Hwy., Buena, NJ 08310..............................
[[Page 46]]
Farmland Industries, Inc., Kansas City, MO 64116............ 021676
Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013- 017135
3928.......................................................
Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, 030841
Mankato, MN 56001..........................................
John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611....... 058034
First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123... 058829
Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 015565
28234......................................................
Fort Dodge Animal Health, A Division of Wyeth Holdings 053501
Corp., P.O. Box 1339, Fort Dodge, IA 50501.................
Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. 000856
NW., Fort Dodge, IA 50501..................................
Furst-McNess Co., Freeport, IL 61032........................ 010439
Gossett Nutrition, Inc., 1676 Cascade Dr., Marion, OH 43302. 050972
G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 010515
13201......................................................
Halocarbon Laboratories, Division of Halocarbon Products 012164
Corp., 887 Kinderkamack Rd., P.O. Box 661, River Ridge, NJ
07661......................................................
Happy Jack, Inc., Snow Hill, NC 28580....................... 023851
Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525... 063604
Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511.. 050749
IDEXX Pharmaceuticals, Inc., 4249-105 Piedmont Pkwy., 065274
Greensboro, NC 27410.......................................
I.M.S. Inc., 13619 Industrial Rd., Omaha, NE 68137.......... 050639
IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 000115
94544......................................................
International Nutrition, Inc., 7706 `I' Plaza, Omaha, NE 043733
68127......................................................
Intervet Inc., P.O. Box 318, 29160 Intervet Lane............ 057926
Ivy Laboratories, Div. of Ivy Animal Health, Inc., 8857 Bond 021641
Street, Overland Park, KS 66214............................
J. C. Feed Mills, 1050 Sheffield, P.O. Box 224, Waterloo, IA 039741
50704......................................................
Jorgensen Laboratories, Inc., 1450 North Van Buren Ave., 045087
Loveland, CO 80538.........................................
K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214... 038782
Kerber Milling Co., Box 152, 1817 E. Main St., Emmetsburg, 029341
IA 50536...................................................
Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601....... 061690
Luitpold Pharmaceuticals, Inc., Animal Health Division, 010797
Shirley, NY 11967..........................................
M & M Livestock Products Co., Eagle Grove, IA 50533......... 026282
Macleod Pharmaceuticals, Inc., 2600 Canton Ct., Fort 058711
Collins, CO 80525..........................................
Marsam Pharmaceuticals, LLC, Bldg. 31, 24 Olney Ave., Cherry 000209
Hill, NJ 08034.............................................
Medicis Dermatologics, Inc., 8125 North Hayden Rd., 099207
Scottsdale, AZ 85258.......................................
Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767- 051259
1861.......................................................
Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 050604
30096-4640.................................................
Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX 047126
79105......................................................
Mid-Continent Agrimarketing, Inc., 8833 Quivira Rd., 059620
Overland Park, KS 66214....................................
Minrad, Inc., 836 Main St., 2d floor, Buffalo, NY 14202..... 060307
Monsanto Co., 800 North Lindbergh Blvd., St. Louis, MO 63167 000911
Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, 049968
MS 39120...................................................
Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, 055529
Northern Ireland...........................................
Norco Mills of Norfolk, Inc., P.O. Box 56, Norfolk, NE 68701 027190
North American Nutrition Companies, Inc., C.S. 5002, 6531 017790
St., Rt. 503, Lewisburg, OH 45338..........................
Novartis Animal Health US, Inc., 3200 Northline Ave., suite 058198
300, Greensboro, NC 27408..................................
Nutra-Blend Corp., P.O. Box 485, Neosho, MO 64850........... 050568
NutriBasics Co., North Highway 71, P.O. Box 1014, WIllmar, 053740
MN 56201...................................................
Nylos Trading Co., Inc., P.O. Box 2, Route 202, Pomona, NY 027454
10970......................................................
Orion Corp., Orionintie 1, 02200 Espoo, Finland............. 052483
Orphan Medical, Inc., 13911 Ridgedale Dr., Suite 475, 062161
Minnetonka, MN 55305.......................................
OXIS International, Inc., 6040 N. Cutter Circle, Suite 317, 024991
Portland, OR 97217-3935....................................
Parnell Laboratories (Aust) Pty. Ltd., Century Estate, unit 068504
6, 476 Gardeners Rd., Alexandria, New South Wales 2015,
Australia..................................................
Peavey Co., 730 Second Ave. South, Minneapolis, MN 55402.... 028459
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 055246
32514......................................................
Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144.... 048164
Peptech Animal Health Pty, Ltd., 35-41 Waterloo Rd., North 064288
Ryde, New South Wales 2113, Australia......................
Pfizer, Inc., 235 East 42d St., New York, NY 10017.......... 000069
Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 000009
42d St., New York, NY 10017................................
Phibro Animal Health, 65 Challenger Rd., 3d floor, 066104
Ridgefield Park, NJ 07660..................................
Phoenix Pharmaceutical, Inc., 4621 Easton Rd., P.O. Box 6457 057319
Farleigh Station, St. Joseph, MO 64506-0457................
Phoenix Scientific, Inc., 3915 South 48th Street Ter., St. 059130
Joseph, MO 64503...........................................
Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, 060728
Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Paulo,
Brazil.....................................................
Pliva d.d., Ulica grada Vukovara 49, 10000 Zagreb, Croatia.. 011722
PR Pharmaceuticals, Inc., 1716 Heath Pkwy., Fort Collins, CO 067210
80524......................................................
Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-6812 017800
Quali-Tech Products, Inc., 318 Lake Hazeltine Drive, Chaska, 016968
MN 55318...................................................
Rhodia Limited, P.O. Box 46, St. Andrews Rd., Avonmouth, 059258
Bristol BS11 9YF, England, UK..............................
Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. 068287
Box 8500, Mankato, MN 56002-8500...........................
Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., P.O. 067949
Box 8500, Mankato, MN 56002-8500...........................
RMS Laboratories, Inc., 1903 East First St., Vidalia, GA 067292
30474......................................................
[[Page 47]]
Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 063238
07054-1298.................................................
RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620.... 058670
R. P. Scherer North America, P.O. Box 5600, Clearwater, FL 011014
33518......................................................
Schering-Plough Animal Health Corp., 1095 Morris Ave., 000061
Union, NJ 07083............................................
G. D. Searle LLC, Pharmacia Corp., 4901 Searle Pkwy., 000014
Skokie, IL 60077...........................................
Seeco Inc., Box 1014, North Highway 71, Willmar, MN 56201... 011749
Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 063112
51250......................................................
South St. Paul Feeds, Inc., 500 Farwell Ave., South St. 001800
Paul, MN 55075.............................................
Southern Micro-Blenders, Inc., 3801 North Hawthorne St., 049685
Chattanooga, TN 37406......................................
Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., 058005
Lenexa, KS 66215...........................................
Springfield Milling Corp., Vigorena Feeds, Springfield, MN 035955
56087......................................................
Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151... 017153
Steris Laboratories, Inc., 620 North 51st Ave., Phoenix, AZ 000402
85043-4705.................................................
Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752.. 037990
Technology Transfer, Inc., 33 East Broadway, suite 190, 067647
Columbia, MO 65203.........................................
Teva Pharmaceuticals USA, 650 Cathill Rd., Sellersville, PA 000093
18960......................................................
Texas Vitamin Co., P.O. Box 18417, 10695 Aledo St., Dallas, 000842
TX 57218...................................................
Triple ``F'', Inc., 10104 Douglas Ave., Des Moines, IA 50322 011490
United Vaccines, A Harlan Sprague Dawley, Inc., Co., P.O. 058639
Box 4220, Madison, WI 53711................................
Vetem, S.p.A., Viale E. Bezzi 24, 20146 Milano, Italy....... 055882
Veterinary Research Associates, Inc., 2817 West Country Rd. 064408
54G, Fort Collins, CO 80524................................
Veterinary Service, Inc., 416 North Jefferson St., P.O. Box 033008
2467, Modesto, CA 95354....................................
Veterinary Specialties Inc., 387 North Valley Ct., 062925
Barrington, IL 60010.......................................
V[eacute]toquinol N.-A., Inc., 2000 chemin Georges, 059320
Lavaltrie (PQ), Canada, J5T 3S5............................
Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137.... 051311
Walco International, Inc., 15 West Putnam, Porterville, CA 049185
93257
Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704.. 017139
Wayne Feed Division, Continental Grain Co., P.O. Box 459, 034936
Libertyville, IL 60048.....................................
Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363............. 035098
Wellmark International, 1501 East Woodfield Rd., suite 200 011536
West, Schaumburg, IL 60173.................................
Wendt Laboratories , Inc., 100 Nancy Dr., Belle Plaine, MN 015579
56011......................................................
West Agro, Inc., 11100 N. Congress Ave., Kansas City, MO 033392
64153......................................................
Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 050378
98248......................................................
West-Ward Pharmaceutical Corp., 465 Industrial Way West, 000143
Eatontown, NJ 07724........................................
Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort 053923
Collins, CO 80524..........................................
Wyeth Laboratories, Division American Home Products Corp., 000008
P.O. Box 8299, Philadelphia, PA 19101......................
Yoder Feed, Division of Yoder, Inc., Kalona, IA 52247....... 035369
------------------------------------------------------------------------
(2) Numerical Listing of Sponsors
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
000008............................. Wyeth Laboratories, Division
American Home Products Corp., P.O.
Box 8299, Philadelphia, PA 19101.
000009............................. Pharmacia & Upjohn Co., a Division
of Pfizer, Inc., 235 East 42d St.,
New York, NY 10017.
000010............................. Boehringer Ingelheim Vetmedica,
Inc., 2621 North Belt Highway, St.
Joseph, MO 64506-2002.
000014............................. G. D. Searle LLC, Pharmacia Corp.,
4901 Searle Pkwy., Skokie, IL
60077.
000061............................. Schering-Plough Animal Health
Corp., 1095 Morris Ave., Union, NJ
07083.
000069............................. Pfizer, Inc., 235 East 42d St., New
York, NY 10017.
000074............................. Abbott Laboratories, North Chicago,
IL 60064.
000093............................. Teva Pharmaceuticals USA, 650
Cathill Rd., Sellersville, PA
18960.
000115............................. IMPAX Laboratories, Inc., 30831
Huntwood Ave., Hayward, CA 94544.
000143............................. West-Ward Pharmaceutical Corp., 465
Industrial Way West, Eatontown, NJ
07724
000185............................. Eon Labs Manufacturing, Inc., 227-
15 North Conduit Ave., Laurelton,
NY 11413.
000209............................. Marsam Pharmaceuticals, LLC, Bldg.
31, 24 Olney Ave., Cherry Hill, NJ
08034.
000332............................. Biocraft Laboratories, Inc., 92
Route 46, Elmwood Park, NJ 07407.
000402............................. Steris Laboratories, Inc., 620
North 51st Ave., Phoenix, AZ 85043-
4705.
000842............................. Texas Vitamin Co., P.O. Box 18417,
10695 Aledo St., Dallas, TX 57218.
000856............................. Fort Dodge Animal Health, Division
of Wyeth, 800 Fifth St. NW., Fort
Dodge, IA 50501.
000859............................. Bayer HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee
Mission, KS 66201
000911............................. Monsanto Co., 800 North Lindbergh
Blvd., St. Louis, MO 63167.
000986............................. Elanco Animal Health, A Division of
Eli Lilly & Co., Lilly Corporate
Center, Indianapolis, IN 46285.
001800............................. South St. Paul Feeds, Inc., 500
Farwell Ave., South St. Paul, MN
55075.
010019............................. Baxter Healthcare Corp., 95 Spring
St., New Providence, NJ 07974.
010237............................. Church & Dwight Co., Inc., 469
North Harrison St., Princeton, NJ
08543-5297.
010439............................. Furst-McNess Co., Freeport, IL
61032.
010515............................. G. C. Hanford Manufacturing Co.,
P.O. Box 1017, Syracuse, NY 13201.
010797............................. Luitpold Pharmaceuticals, Inc.,
Animal Health Division, Shirley,
NY 11967.
011014............................. R. P. Scherer North America, P.O.
Box 5600, Clearwater, FL 33518.
[[Page 48]]
011490............................. Triple ``F'', Inc., 10104 Douglas
Ave., Des Moines, IA 50322.
011536............................. Wellmark International, 1501 East
Woodfield Rd., suite 200 West,
Schaumburg, IL 60173
011722............................. Pliva d.d., Ulica grada Vukovara
49, 10000 Zagreb, Croatia
011749............................. Seeco Inc., Box 1014, North Highway
71, Willmar, MN 56201.
012164............................. Halocarbon Laboratories, Division
of Halocarbon Products Corp., 887
Kinderkamack Rd., P.O. Box 661,
River Ridge, NJ 07661.
015565............................. Fleming Laboratories, Inc., P.O.
Box 34384, Charlotte, NC 28234.
015579............................. Wendt Laboratories, Inc., 100 Nancy
Dr., Belle Plaine, MN 56011.
016968............................. Quali-Tech Products, Inc., 318 Lake
Hazeltine Dr., Chaska, MN 55318.
017030............................. Evsco Pharmaceuticals, An Affiliate
of IGI, Inc., Box 209, Harding
Hwy., Buena, NJ 08310.
017135............................. Farnam Companies, Inc., 301 West
Osborn, Phoenix, AZ 85013-3928.
017139............................. Waterloo Mills Co., 2050 Mitchell
Ave., Waterloo, IA 50704.
017153............................. Squire Laboratories, Inc., 100 Mill
St., Revere, MA 02151.
017473............................. Custom Feed Services Corp., 2100 N.
13th St., Norfolk, NE 68701.
017519............................. ADM Animal Health & Nutrition
Division, 1000 North 30th St., Box
1C, Quincy, IL 62305-3115
017762............................. Agri-Tech, Inc., 4722 Broadway,
Kansas City, MO 64112.
017790............................. North American Nutrition Companies,
Inc., C.S. 5002, 6531 St., Rt.
503, Lewisburg, OH 45338.
017800............................. Purina Mills, Inc., P.O. Box 66812,
St. Louis, MO 63166-6812.
021091............................. ConAgra Pet Products Co., 3902
Leavenworth St., Omaha, NE 68105.
021641............................. Ivy Laboratories, Div. of Ivy
Animal Health, Inc., 8857 Bond
Street, Overland Park, KS 66214.
021676............................. Farmland Industries, Inc., Kansas
City, MO 64116.
021930............................. ADM Alliance Nutrition, Inc., 1000
North 30th St., Quincy, IL 62305-
3115
023851............................. Happy Jack, Inc., Snow Hill, NC
28580.
024174............................. Ag-Mark, Inc., P.O. Box 127,
Teachey, NC 28464.
024991............................. OXIS International, Inc., 6040 N.
Cutter Circle, Suite 317 Portland,
OR 97217-3935.
025463............................. Altana Inc., 60 Baylis Rd.,
Melville, NY 11747.
026282............................. M & M Livestock Products Co., Eagle
Grove, IA 50533.
027190............................. Norco Mills of Norfolk, Inc., P.O.
Box 56, Norfolk, NE 68701.
027454............................. Nylos Trading Co., Inc., P.O. Box
2, Route 202, Pomona, NY 10970.
028459............................. Peavey Co., 730 Second Ave. South,
Minneapolis, MN 55402.
029341............................. Kerber Milling Co., Box 152, 1817
E. Main St., Emmetsburg, IA 50536.
030841............................. Feed Service Co., Inc., 303 Lundin
Blvd., P.O. Box 698, Mankato, MN
56001.
032761............................. BioScience Division of Milk
Specialties Co., 1902 Tennyson
Lane, Madison, WI 53704
033008............................. Veterinary Service, Inc., 416 North
Jefferson St., P.O. Box 2467,
Modesto, CA 95354.
033392............................. West Agro, Inc., 11100 N. Congress
Ave., Kansas City, MO 64153.
034936............................. Wayne Feed Division, Continental
Grain Co., P.O. Box 459,
Libertyville, IL 60048.
035098............................. Webel Feeds, Inc., R.R. 3,
Pittsfield, IL 62363.
035369............................. Yoder Feed, Division of Yoder,
Inc., Kalona, IA 52247.
035955............................. Springfield Milling Corp., Vigorena
Feeds, Springfield, MN 56087.
037990............................. Summit Hill Laboratories, P.O. Box
535, Navesink, NJ 07752.
038782............................. K. C. Pharmacal, Inc., 8345 Melrose
Dr., Lenexa, KS 66214.
039741............................. J. C. Feed Mills, 1050 Sheffield,
P.O. Box 224, Waterloo, IA 50704.
043733............................. International Nutrition, Inc., 7706
`I' Plaza, Omaha, NE 68127
045087............................. Jorgensen Laboratories, Inc., 1450
North Van Buren Ave., Loveland, CO
80538.
046573............................. Alpharma Inc., One Executive Drive,
Fort Lee, NJ 07024.
046987............................. Custom Feed Blenders Corp., 540
Hawkeye Ave., Fort Dodge, IA
50501.
047126............................. Micro Beef Technologies LTD, P.O.
Box 9262, Amarillo, TX 79105.
048164............................. Pennfield Oil Co., 14040 Industrial
Rd., Omaha, NE 68144.
049185............................. Walco International, Inc., 15 West
Putnam, Porterville, CA 93257.
049685............................. Southern Micro-Blenders, Inc., 3801
North Hawthorne St., Chattanooga,
TN 37406.
049968............................. Natchez Animal Supply Co., 201 John
R. Junkin Dr., Natchez, MS 39120.
050378............................. Western Chemical, Inc., 1269
Lattimore Rd., Ferndale, WA 98248.
050568............................. Nutra-Blend Corp., P.O. Box 485,
Neosho, MO 64850.
050604............................. Merial Ltd., 3239 Satellite Blvd.,
Bldg. 500, Duluth, GA 30096-4640.
050639............................. I.M.S. Inc., 13619 Industrial Rd.,
Omaha, NE 68137.
050749............................. Hess & Clark, Inc., 944 Nandino
Blvd., Lexington, KY 40511.
050972............................. Gossett Nutrition, Inc., 1676
Cascade Dr., Marion, OH 43302.
051212............................. Argent Laboratories, 8702 152d Ave.
NE., Redmond, WA 98052.
051259............................. Med-Pharmex, Inc., 2727 Thompson
Creek Rd., Pomona, CA 91767-1861.
051267............................. Cooperative Research Farms, Box 69,
Charlotteville, NY 12036.
051311............................. Virbac AH, Inc., 3200 Meacham
Blvd., Ft. Worth, TX 76137.
051359............................. Bioproducts, Inc., 320 Springside
Dr., Suite 300, Fairlawn, OH
44141.
052483............................. Orion Corp., Orionintie 1, 02200
Espoo, Finland.
053501............................. Fort Dodge Animal Health, A
Division of Wyeth Holdings Corp.,
P.O. Box 1339, Fort Dodge, IA
50501.
053740............................. NutriBasics Co., North Highway 71,
P.O. Box 1014, WIllmar, MN 56201.
[[Page 49]]
053923............................. Wildlife Laboratories, Inc., 1401
Duff Dr., Suite 600, Fort Collins,
CO 80524.
055246............................. Pegasus Laboratories, Inc., 8809
Ely Rd., Pensacola, FL 32514.
055462............................. Contemporary Products, Inc., 3788
Elm Springs Rd., Springdale, AR
72764-6067.
055529............................. Norbrook Laboratories, Ltd.,
Station Works, Newry BT35 6JP,
Northern Ireland.
055882............................. Vetem, S.p.A., Viale E. Bezzi 24,
20146 Milano, Italy.
057319............................. Phoenix Pharmaceutical, Inc., 4621
Easton Rd., P.O. Box 6457 Farleigh
Station, St. Joseph, MO 64506-
0457.
057561............................. Agri Laboratories, Ltd., P.O. Box
3103, St. Joseph, MO 64503.
057926............................. Intervet, Inc., P.O. Box 318, 29160
Intervet Lane.
058005............................. Sparhawk Laboratories, Inc., 12340
Santa Fe Trail Dr., Lenexa, KS
66215.
058034............................. John J. Ferrante, 11 Fairway Lane,
Trumbull, CT 06611.
058198............................. Novartis Animal Health US, Inc.,
3200 Northline Ave., suite 300,
Greensboro, NC 27408.
058639............................. United Vaccines, A Harlan Sprague
Dawley, Inc., Co., P.O. Box 4220,
Madison, WI 53711.
058670............................. RSR Laboratories, Inc., 501 Fifth
St., Bristol, TN 37620.
058711............................. Macleod Pharmaceuticals, Inc., 2600
Canton Ct., Fort Collins, CO
80525.
058829............................. First Priority, Inc., 1585 Todd
Farm Dr., Elgin, IL 60123.
059130............................. Phoenix Scientific, Inc., 3915
South 48th Street Ter., St.
Joseph, MO 64503
059258............................. Rhodia Limited, P.O. Box 46, St.
Andrews Rd., Avonmouth, Bristol
BS11 9YF, England, UK.
059320............................. V[eacute]toquinol N.-A., Inc., 2000
chemin Georges, Lavaltrie (PQ),
Canada, J5T 3S5.
059521............................. Ausa International, Inc., Rt. 8,
P.O. Box 324-12, Tyler, TX 75703.
059620............................. Mid-Continent Agrimarketing, Inc.,
8833 Quivira Rd., Overland Park,
KS 66214.Blvd., St. Louis, MO
63167.
060307............................. Minrad, Inc., 836 Main St., 2d
floor, Buffalo, NY 14202.
060728............................. Planalquimica Industrial Ltda., Rua
das Magnolias nr. Jardim das
Bandeiras, CEP 13053-120,
Campinas, Sao Alto, Brazil.
060865............................. Anika Therapeutics Inc., 236 West
Cummings Park, Woburn, MA 01801.
060951............................. Endo Pharmaceuticals, Inc., 100
Painters Dr., Chadds Ford, PA
19317.
061623............................. Cross Vetpharm Group Ltd.,
Broomhill Rd., Tallaght, Dublin
24, Ireland.
061651............................. Chanelle Pharmaceuticals
Manufacturing Ltd., Loughrea,
County Galway, Ireland.
061690............................. Lloyd, Inc., 604 W. Thomas Ave.,
Shenandoah, IA 51601.
062161............................. Orphan Medical, Inc., 13911
Ridgedale Dr., Suite 475,
Minnetonka, MN 55305.
062408............................. Alstoe, Ltd., Animal Health, Pera
Innovation Park, Nottingham Rd.,
Melton Mowbray, Leicestershire,
England LE13 0PB.
062794............................. Bertek Pharmaceuticals, Inc., 12720
Dairy Ashford, Sugar Land, TX
77478
062925............................. Veterinary Specialties Inc., 387
North Valley Ct., Barrington, Il
60010.
063075............................. Biopure Corp., 11 Hurley St.,
Cambridge, MA 02141.
063112............................. Sioux Biochemical, Inc., 204 Third
St. NW., Sioux Center, IA 51250.
063238............................. Roche Vitamins, Inc., 45 Waterview
Blvd., Parsippany, NJ 07054-1298.
063323............................. American Pharmaceuticals Partners,
Inc., 2045 North Cornell Ave.,
Melrose Park, IL 60160.
063604............................. Heska Corp., 1825 Sharp Point Dr.,
Fort Collins, CO 80525.
063765............................. Akzo Nobel Surface Chemistry AB,
Box 851, S-44485 Stenungsund,
Sweden.
064146............................. Alaco, Inc., 1500 North Wilmot Rd.,
suite 290-C, Tucson, AZ 85712.
064288............................. Peptech Animal Health Pty, Ltd., 35-
41 Waterloo Rd., North Ryde, New
South Wales 2113, Australia.
064408............................. Veterinary Research Associates,
Inc., 2817 West Country Rd. 54G,
Fort Collins, CO 80524
064847............................. Bioniche Animal Health USA, Inc.,
119 Rowe Rd., Athens, GA 30601
065274............................. IDEXX Pharmaceuticals, Inc., 4249-
105 Piedmont Pkwy., Greensboro, NC
27410
066104............................. Phibro Animal Health, 65 Challenger
Rd., 3d floor, Ridgefield Park, NJ
07660
066916............................. ECO LLC, 8209 Hollister Ave., Las
Vegas, NV 89131
067210............................. PR Pharmaceuticals, Inc., 1716
Heath Pkwy., Fort Collins, CO
80524
067292............................. RMS Laboratories, Inc., 1903 East
First St., Vidalia, GA 30474
067647............................. Technology Transfer, Inc., 33 East
Broadway, suite 190, Columbia, MO
65203
067949............................. Ridley U.S. Holdings, Inc., 424 N.
Riverfront Dr., P.O. Box 8500,
Mankato, MN 56002-8500
068287............................. Ridley Block Operations Inc., 424
North Riverfront Dr., P.O. Box
8500, Mankato, MN 56002-8500
068504............................. Parnell Laboratories (Aust) Pty.
Ltd., Century Estate, unit 6, 476
Gardeners Rd., Alexandria, New
South Wales 2015, Australia
068718............................. Animal Health Pharmaceuticals, LLC,
1805 Oak Ridge Circle, suite 101,
St. Joseph, MO 64506
099207............................. Medicis Dermatologics, Inc., 8125
North Hayden Rd., Scottsdale, AZ
85258
------------------------------------------------------------------------
[40 FR 13807, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting Sec.
510.600, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.
PART 511_NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE--Table of Contents
Authority: 21 U.S.C. 321, 351, 352, 353, 360b, 371.
[[Page 50]]
Sec. 511.1 New animal drugs for investigational use exempt from section
512(a) of the act.
(a) New animal drugs for tests in vitro and in laboratory research
animals. (1) A shipment or other delivery of a new animal drug or animal
feed bearing or containing a new animal drug intended solely for tests
in vitro or in animals used only for laboratory research purposes shall
be exempt from section 512 (a) and (m) of the act if it is labeled as
follows:
Caution. Contains a new animal drug for investigational use only in
laboratory research animals or for tests in vitro. Not for use in
humans.
(2) The person distributing or causing the distribution of new
animal drugs for tests in vitro or in animals used only for laboratory
research purposes under this exemption shall use due diligence to assure
that the consignee is regularly engaged in conducting such tests and
that the shipment of the new animal drug will actually be used for tests
in vitro or in animals used only for laboratory research.
(3) The person who introduced such shipment or who delivered the new
animal drug for introduction into interstate commerce shall maintain
adequate records showing the name and post office address of the expert
or expert organization to whom the new animal drug is shipped and the
date, quantity, and batch or code mark of each shipment and delivery for
a period of 2 years after such shipment and delivery. Upon the request
of a properly authorized employee of the Department at reasonable times,
he shall make such records available for inspection and copying.
(4) The exemption allowed in this paragraph shall not apply to any
new animal drug intended for in vitro use in the regular course of
diagnosing or treating disease, including antibacterial sensitivity
discs impregnated with any new animal drug or drugs, which discs are
intended for use in determining susceptibility of microorganisms to the
new animal drug or drugs.
(b) New animal drugs for clinical investigation in animals. A
shipment or other delivery of a new animal drug or an animal feed
containing a new animal drug intended for clinical investigational use
in animals shall be exempt from section 512(a) and (m) of the act if all
the following conditions are met:
(1) The label shall bear the statements:
Caution. Contains a new animal drug for use only in investigational
animals in clinical trials. Not for use in humans. Edible products of
investigational animals are not to be used for food unless authorization
has been granted by the U.S. Food and Drug Administration or by the U.S.
Department of Agriculture.
In the case of containers too small or otherwise unable to
accommodate a label with sufficient space to bear the caution statements
required by paragraph (a) or (b) of this section, the statements may be
included on the carton label and other labeling on or within the package
from which the new animal drug is to be dispensed.
(2) The person or firm distributing or causing the distribution of
the new animal drug or animal feed containing a new animal drug shall
use due diligence to assure that the new animal drug or animal feed
containing a new animal drug will actually be used for tests in animals
and is not used in humans.
(3) The person who introduced such shipment or who delivered the new
animal drug or animal feed containing a new animal drug for introduction
into interstate commerce shall maintain adequate records showing the
name and post office address of the investigator to whom the new animal
drug or animal feed containing a new animal drug is shipped and the
date, quantity, and batch or code mark of each shipment and delivery for
a period of 2 years after such shipment and delivery. Upon the request
of a properly authorized employee of the Department at reasonable times,
such records shall be made available for inspection and copying.
(4) Prior to shipment of the new animal drug for clinical tests in
animals, the sponsor of the investigation shall submit in triplicate to
the Food and Drug Administration a ``Notice of Claimed Investigational
Exemption for a New Animal Drug'' including a signed statement
containing the following information:
[[Page 51]]
(i) The identity of the new animal drug.
(ii) All labeling and other pertinent information to be supplied to
the investigators. When such pertinent information includes nonclinical
laboratory studies, the information shall include, with respect to each
nonclinical study, either a statement that the study was conducted in
compliance with the requirements set forth in part 58 of this chapter,
or, if the study was not conducted in compliance with such regulations,
a brief statement of the reason for the noncompliance.
(iii) The name and address of each clinical investigator.
(iv) The approximate number of animals to be treated (or if not
available, the amount of new animal drug to be shipped).
(v) If the new animal drug is given to food-producing animals, the
statement shall contain the following additional information:
(a) A commitment that the edible products from such animals shall
not be used for food without prior authorization in accordance with the
provisions prescribed in this section.
(b) Approximate dates of the beginning and end of the experiment or
series of experiments.
(c) The maximum daily dose(s) to be administered to a given species,
the size of animal, maximum duration of administration, method(s) of
administration, and proposed withdrawal time, if any.
(vi) If a sponsor has transferred any obligations for the conduct of
any clinical study to a contract research organization, a statement
containing the name and address of the contract research organization,
identification of the clinical study, and a listing of the obligations
transferred. If all obligations governing the conduct of the study have
been transferred, a general statement of this transfer--in lieu of a
listing of the specific obligations transferred--may be submitted.
(5) Authorization for use of edible products derived from a treated
food-producing animal may be granted under the provisions of this
section and when the following specified conditions are met, except that
in the case of an animal administered any unlicensed experimental
veterinary biological product regulated under the viruses, serums,
toxins statute (21 U.S.C., chapter V, sec. 151 et seq. ) the product
shall be exempt from the requirements of this section when U.S.
Department of Agriculture approval has been obtained as provided in 9
CFR 103.2. Conditional authorization may be granted in advance of
identification of the name(s) and address(es) of the clinical
investigator(s) as required by paragraph (b)(4)(iii) of this section.
Information required for authorization shall include, in addition to all
other requirements of this section, the following:
(i) Data to show that consumption of food derived from animals
treated at the maximum levels with the minimum withdrawal periods, if
any, specified in accordance with paragraph (b)(4)(v)(c) of this
section, will not be inconsistent with the public health; or
(ii) Data to show that food derived from animals treated at the
maximum levels and with the minimum withdrawal periods, if any,
specified in accordance with paragraph (b)(4)(v)(c) of this section,
does not contain drug residues or metabolites.
(iii) The name and location of the packing plant where the animals
will be processed, except that this requirement may be waived, on
request, by the terms of the authorization.
Authorizations granted under this paragraph do not exempt
investigational animals and their products from compliance with other
applicable inspection requirements. Any person who contests a refusal to
grant such authorization shall have an opportunity for a regulatory
hearing before the Food and Drug Administration pursuant to part 16 of
this chapter.
(6) On written request of the Food and Drug Administration, the
sponsor shall submit any additional information reported to or otherwise
received by him with respect to the investigation deemed necessary to
facilitate a determination whether there are grounds in the interest of
public health for terminating the exemption.
(7) The sponsor shall assure himself that the new animal drug is
shipped only to investigators who:
(i) Are qualified by scientific training and/experience to evaluate
the safety
[[Page 52]]
and/or effectiveness of the new animal drug.
(ii) Shall maintain complete records of the investigations,
including complete records of the receipt and disposition of each
shipment or delivery of the new animal drug under investigation. Copies
of all records of the investigation shall be retained by the
investigator for 2 years after the termination of the investigation or
approval of a new animal drug application.
(iii) Shall furnish adequate and timely reports of the investigation
to the sponsor.
(8) The sponsor:
(i) Shall retain all reports received from investigators for 2 years
after the termination of the investigation or approval of a new animal
drug application and make such reports available to a duly authorized
employee of the Department for inspection at all reasonable times.
(ii) Shall provide for current monitoring of the investigation by a
person qualified by scientific training and experience to evaluate
information obtained from the investigation, and shall promptly
investigate and report to the Food and Drug Administration and to all
investigators any findings associated with use of the new animal drug
that may suggest significant hazards pertinent to the safety of the new
animal drug.
(iii) Shall not unduly prolong distribution of the new animal drug
for investigational use.
(iv) Shall not, nor shall any person acting for or on behalf of the
sponsor, represent that the new animal drug is safe or effective for the
purposes for which it is under investigation. This requirement is not
intended to restrict the full exchange of scientific information.
(v) Shall not commercially distribute nor test-market the new animal
drug until a new animal drug application is approved pursuant to section
512(c) of the act.
(9) If the shipment or other delivery of the new animal drug is
imported or offered for importation into the United States for clinical
investigational use in animals, it shall also meet the following
conditions:
(i) The importer of all such shipments or deliveries is an agent of
the foreign exporter residing in the United States or the ultimate
consignee, which person has, prior to such shipments and deliveries,
informed the Food and Drug Administration of his intention to import the
new animal drug as sponsor in compliance with the conditions prescribed
in this subdivision; or
(ii) The new animal drug is shipped directly to a scientific
institution with adequate facilities and qualified personnel to conduct
laboratory or clinical investigations and is intended solely for use in
such institutions and which institution has submitted a statement as
sponsor of the investigation.
(10) The sponsor shall submit either a claim for categorical
exclusion under Sec. 25.30 or Sec. 25.33 of this chapter or an
environmental assessment under Sec. 25.40 of this chapter.
(c) Withdrawal of eligibility to receive investigational-use new
animal drugs. (1) Whenever the Food and Drug Administration has
information indicating that an investigator has repeatedly or
deliberately failed to comply with the conditions of these exempting
regulations or has submitted false information either to the sponsor of
the investigation or in any required report, the Center for Veterinary
Medicine will furnish the investigator written notice of the matter
complained of in general terms and offer him an opportunity to explain
the matter in an informal conference and/or in writing. If an
explanation is offered but not accepted by the Center for Veterinary
Medicine, the investigator shall have an opportunity for a regulatory
hearing before the Food and Drug Administration pursuant to part 16 of
this chapter on the question of whether the investigator is entitled to
receive investigational new animal drugs.
(2) If, after evaluating all available information, including any
explanation presented by the investigator, the Commissioner determines
that the investigator has repeatedly or deliberately failed to comply
with the conditions of the exempting regulations in this section or has
repeatedly or deliberately submitted false information to
[[Page 53]]
the sponsor of an investigation, the Commissioner will notify the
investigator and the sponsor of any investigation in which he has been
named as a participant that the investigator is not entitled to receive
investigational use new animal drugs with a statement of the basis for
such determination.
(3) Each ``Notice of Claimed Investigational Exemption for a New
Animal Drug'' and each approved new animal drug application containing
data reported by an investigator who has been determined to be
ineligible to receive investigational-use new animal drugs will be
examined to determine whether he has submitted unreliable data that are
essential to the continuation of the investigation or essential to the
approval of any new animal drug application.
(4) If the Commissioner determines, after the unreliable data
submitted by the investigator are eliminated from consideration, that
the data remaining are inadequate to support a conclusion that it is
reasonably safe to continue the investigation, he shall first notify the
sponsor, who shall have an opportunity for a regulatory hearing before
the Food and Drug Administration pursuant to part 16 of this chapter on
whether the exemption should be terminated. If a danger to the public
health exists, however, he shall terminate the exemption forthwith and
notify the sponsor of the termination. In such event the sponsor shall
have an opportunity for a regulatory hearing before the Food and Drug
Administration pursuant to part 16 (see 42 FR 15675, March 22, 1977) of
this chapter on the question of whether the exemption should be
reinstated.
(5) If the Commissioner determines, after the unreliable data
submitted by the investigator are eliminated from consideration, that
the data remaining are such that a new animal drug application would not
have been approved, he will proceed to withdraw approval of the
application in accordance with section 512(e) of the act.
(6) An investigator who has been determined to be ineligible may be
reinstated as eligible to receive investigational-use new animal drugs
when the Commissioner determines that he has presented adequate
assurance that he will employ such new animal drugs solely in compliance
with the exempting regulations in this section for investigational-use
new animal drugs.
(d) Termination of exemption. If the Commissioner finds that:
(1) The sponsor of the investigation has failed to comply with any
of the conditions for the exemption established under this section, or
(2) The continuance of the investigation is unsafe or otherwise
contrary to the public interest or the drug is being or has been used
for purposes other than bona fide scientific investigation, he shall
first notify the sponsor and invite his immediate correction. If the
conditions of the exemption are not immediately met, the sponsor shall
have an opportunity for a regulatory hearing before the Food and Drug
Administration pursuant of part 16 of this chapter on whether the
exemption should be terminated. If the exemption is terminated the
sponsor shall recall or have destroyed the unused supplies of the new
animal drug.
(e) Statements and requests. ``Notice(s) of Claimed Investigational
Exemption for a New Animal Drug'' and requests for authorization to use
investigational animals and their products for food should be addressed
to the Department of Health and Human Services, Food and Drug
Administration, Center for Veterinary Medicine, 7500 Standish Pl.,
Rockville, MD 20855.
(f) Contract research organizations. (1) For purposes of this part
and part 514, contract research organization means a person that
assumes, as an independent contractor with the sponsor, one or more of
the obligations of a sponsor, e.g., design of a protocol, selection or
monitoring of investigations, evaluation of reports, and preparation of
materials to be submitted to the Food and Drug Administration.
(2) A sponsor may transfer responsibility for any or all of the
obligations set forth in this part to a contract research organization.
Any such transfer shall be in writing and, if not all obligations are
transferred, shall describe each of the obligations being assumed by the
contract research organization. If all obligations are transferred, a
general statement that all obligations have been transferred is
acceptable.
[[Page 54]]
Any obligation not covered by the written description shall be deemed
not to have been transferred.
(3) A contract research organization that assumes any obligation of
a sponsor shall comply with the specific regulations in this chapter
applicable to this obligation and shall be subject to the same
regulatory action as a sponsor for failure to comply with any obligation
assumed under these regulations. Thus, all references to sponsor in this
part apply to a contract research organization to the extent that it
assumes one or more obligations of the sponsor.
[40 FR 13823, Mar. 27, 1975, as amended at 41 FR 48268, Nov. 2, 1976; 42
FR 15675, Mar. 22, 1977; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, Apr.
26, 1985; 52 FR 8847, Mar. 19, 1987; 54 FR 18280, Apr. 28, 1989; 57 FR
6475, Feb. 25, 1992; 62 FR 40599, July 29, 1997]
PART 514_NEW ANIMAL DRUG APPLICATIONS--Table of Contents
Subpart A_General Provisions
Sec.
514.1 Applications.
514.3 Definitions.
514.4 Substantial evidence.
514.5 Presubmission conferences.
514.6 Amended applications.
514.7 Withdrawal of applications without prejudice.
514.8 Supplemental new animal drug applications.
514.11 Confidentiality of data and information in a new animal drug
application file.
514.12 Confidentiality of data and information in an investigational new
animal drug notice.
514.15 Untrue statements in applications.
Subpart B_Administrative Actions on Applications
514.80 Records and reports concerning experience with approved new
animal drugs.
514.100 Evaluation and comment on applications.
514.105 Approval of applications.
514.106 Approval of supplemental applications.
514.110 Reasons for refusing to file applications.
514.111 Refusal to approve an application.
514.115 Withdrawal of approval of applications.
514.116 Notice of withdrawal of approval of application.
514.117 Adequate and well-controlled studies.
514.120 Revocation of order refusing to approve an application or
suspending or withdrawing approval of an application.
514.121 Service of notices and orders.
Subpart C_Hearing Procedures
514.200 Contents of notice of opportunity for a hearing.
514.201 Procedures for hearings.
Subparts D-E [Reserved]
Subpart F_Judicial Review
514.235 Judicial review.
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e, 381.
Source: 40 FR 13825, Mar. 27, 1975, unless otherwise noted.
Subpart A_General Provisions
Sec. 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall
be submitted in the form described in paragraph (b) of this section. If
any part of the application is in a foreign language, an accurate and
complete English translation shall be appended to such part.
Translations of literature printed in a foreign language shall be
accompanied by copies of the original publication. The application must
be signed by the applicant or by an authorized attorney, agent, or
official. If the applicant or such authorized representative does not
reside or have a place of business within the United States, the
application must also furnish the name and post office address of, and
must be countersigned by, an authorized attorney, agent, or official
residing or maintaining a place of business within the United States.
Pertinent information may be incorporated in, and will be considered as
part of, an application on the basis of specific reference to such
information, including information submitted under the provisions of
Sec. 511.1 of this chapter, in the files of the Food and Drug
Administration; however, the reference must be specific in identifying
the information. Any reference to information furnished by a person
other than the applicant may
[[Page 55]]
not be considered unless its use is authorized in a written statement
signed by the person who submitted it.
(b) Applications for new animal drugs shall be submitted in
triplicate and assembled in the manner prescribed by paragraph (b)(15)
of this section, and shall include the following information:
(1) Identification. Whether the submission is an original or
supplemental application; the name and the address of the applicant; the
date of the application; the trade name(s) (if one has been proposed)
and chemical name(s) of the new animal drug. Upon receipt, the
application will be assigned a number NADA ----, which shall be used for
all correspondence with respect to the application.
(2) Table of contents and summary. The application shall be
organized in a cohesive fashion, shall contain a table of contents which
identifies the data and other material submitted, and shall contain a
well-organized summary and evaluation of the data in the following form:
(i) Chemistry:
(a) Chemical structural formula or description for any new animal
drug substance.
(b) Relationship to other chemically or pharmacologically related
drugs.
(c) Description of dosage form and quantitative composition.
(ii) Scientific rationale and purpose the new animal drug is to
serve:
(a) Clinical purpose.
(b) Highlights of laboratory studies: The reasons why certain types
of studies were done or omitted as related to the proposed conditions of
use and to information already known about this class of compounds.
Emphasize any unusual or particularly significant pharmacological
effects or toxicological findings.
(c) Highlights of clinical studies: The rationale of the clinical
study plan showing why types of studies were done, amended, or omitted
as related to laboratory studies and prior clinical experience.
(d) Conclusions: A short statement of conclusions combining the
major points of effectiveness and safety as they relate to the use of
the new animal drug.
(3) Labeling. Three copies of each piece of all labeling to be used
for the article (total of 9).
(i) All labeling should be identified to show its position on, or
the manner in which it is to accompany the market package.
(ii) Labeling for nonprescription new animal drugs should include
adequate directions for use by the layman under all conditions of use
for which the new animal drug is intended, recommended, or suggested in
any of the labeling or advertising sponsored by the applicant.
(iii) Labeling for prescription veterinary drugs should bear
adequate information for use under which veterinarians can use the new
animal drug safely and for the purposes for which it is intended,
including those purposes for which it is to be advertised or
represented, in accord with Sec. 201.105 of this chapter.
(iv) All labeling for prescription or nonprescription new animal
drugs shall be submitted with any necessary use restrictions prominently
and conspicuously displayed.
(v) Labeling for new animal drugs intended for use in the
manufacture of medicated feeds shall include:
(a) Specimens of labeling to be used for such new animal drug with
adequate directions for the manufacture and use of finished feeds for
all conditions for which the new animal drug is intended, recommended,
or suggested in any of the labeling, including advertising, sponsored by
the applicant. Ingredient labeling may utilize collective names as
provided in Sec. 501.110 of this chapter.
(b) Representative labeling proposed to be used for Type B and Type
C medicated feeds containing the new animal drug.
(vi) Draft labeling may be submitted for preliminary consideration
of an application. Final printed labeling will ordinarily be required
prior to approval of an application. Proposed advertising for veterinary
prescription drugs may be submitted for comment or approval.
(4) Components and composition. A complete list of all articles used
for production of the new animal drug including a full list of the
composition of each article:
[[Page 56]]
(i) A full list of the articles used as components of the new animal
drug. This list should include all substances used in the synthesis,
extraction, or other method of preparation of any new animal drug and in
the preparation of the finished dosage form, regardless of whether they
undergo chemical change or are removed in the process. Each component
should be identified by its established name, if any, or complete
chemical name, using structural formulas when necessary for specific
identification. If any proprietary name is used, it should be followed
by a complete quantitative statement of composition. Reasonable
alternatives for any listed component may be specified.
(ii) A full statement of the composition of the new animal drug. The
statement shall set forth the name and amount of each ingredient,
whether active or not, contained in a stated quantity of the new animal
drug in the form in which it is to be distributed (for example, amount
per tablet or milliliter) and a batch formula representative of that to
be employed for the manufacture of the finished dosage form. All
components should be included in the batch formula regardless of whether
they appear in the finished product. Any calculated excess of an
ingredient over the label declaration should be designated as such and
percent excess shown. Reasonable variation may be specified.
(iii) If it is a new animal drug produced by fermentation:
(a) Source and type of microorganism used to produce the new animal
drug.
(b) Composition of media used to produce the new animal drug.
(c) Type of precursor used, if any, to guide or enhance production
of the antibiotic during fermentation.
(d) Name and composition of preservative, if any, used in the broth.
(e) A complete description of the extraction and purification
processes including the names and compositions of the solvents,
precipitants, ion exchange resins, emulsifiers, and all other agents
used.
(f) If the new animal drug is produced by a catalytic hydrogenation
process (such as tetracycline from chlortetracycline), a complete
description of each chemical reaction with graphic formulas used to
produce the new animal drug, including the names of the catalyst used,
how it is removed, and how the new animal drug is extracted and
purified.
(5) Manufacturing methods, facilities, and controls. A full
description of the methods used in, and the facilities and controls used
for, the manufacture, processing, and packing of the new animal drug.
This description should include full information with respect to any new
animal drug in sufficient detail to permit evaluation of the adequacy of
the described methods of manufacture, processing, and packing, and the
described facilities and controls to determine and preserve the
identity, strength, quality, and purity of the new animal drug, and the
following:
(i) If the applicant does not himself perform all the manufacturing,
processing, packaging, labeling, and control operations for any new
animal drug, he shall: Identify each person who will perform any part of
such operations and designate the part; and provide a signed statement
from each such person fully describing, directly or by reference, the
methods, facilities, and controls he will use in his part of the
operation. The statement shall include a commitment that no changes will
be made without prior approval by the Food and Drug Administration,
unless permitted under Sec. 514.8.
(ii) A description of the qualifications, including educational
background and experience, of the technical and professional personnel
who are responsible for assuring that the new animal drug has the
identity, strength, quality, and purity it purports or is represented to
possess, and a statement of their responsibilities.
(iii) A description of the physical facilities including building
and equipment used in manufacturing, processing, packaging, labeling,
storage, and control operations.
(iv) The methods used in the synthesis, extraction, isolation, or
purification of any new animal drug. When the specifications and
controls applied to such new animal drugs are inadequate in themselves
to determine its identity, strength, quality, and purity,
[[Page 57]]
the methods should be described in sufficient detail, including
quantities used, times, temperature, pH, solvents, etc., to determine
these characteristics. Alternative methods or variations in methods
within reasonable limits that do not affect such characteristics of the
new animal drug may be specified. A flow sheet and indicated equations
should be submitted when needed to explain the process.
(v) Precautions to insure proper identity, strength, quality, and
purity of the raw materials, whether active or not, including:
(a) The specifications for acceptance and methods of testing for
each lot of raw material.
(b) A statement as to whether or not each lot of raw materials is
given a serial number to identify it, and the use made of such numbers
in subsequent plant operations.
(vi) The instructions used in the manufacturing, processing,
packaging, and labeling of each dosage form of the new animal drug,
including:
(a) The method of preparation of the master formula records and
individual batch records and the manner in which these records are used.
(b) The number of individuals checking weight or volume of each
individual ingredient entering into each batch of the new animal drug.
(c) A statement as to whether or not the total weight or volume of
each batch is determined at any stage of the manufacturing process
subsequent to making up a batch according to the formula card and, if
so, at what stage and by whom it is done.
(d) The precautions used in checking the actual package yield
produced from a batch of the new animal drug with the theoretical yield.
This should include a description of the accounting for such items as
discards, breakage, etc., and the criteria used in accepting or
rejecting batches of drugs in the event of an unexplained discrepancy.
(e) The precautions used to assure that each lot of the new animal
drug is packaged with the proper label and labeling, including
provisions for labeling storage and inventory control.
(f) Any special precautions used in the operations.
(vii) The analytical controls used during the various stages of the
manufacturing, processing, packaging, and labeling of the new animal
drug, including a detailed description of the collection of samples and
the analytical procedures to which they are subjected. The analytical
procedures should be capable of determining the active components within
a reasonable degree of accuracy and of assuring the identity of such
components.
(a) A description of practicable methods of analysis of adequate
sensitivity to determine the amount of the new animal drug in the final
dosage form should be included. The dosage form may be a finished
pharmaceutical product, a Type A medicated article, a Type B or a Type C
medicated feed, or a product for use in animal drinking water. Where two
or more active ingredients are included, methods should be quantitative
and specific for each active ingredient.
(b) If the article is one that is represented to be sterile, the
same information with regard to the manufacturing, processing,
packaging, and the collection of samples of the drug should be given for
sterility controls. Include the standards used for acceptance of each
lot of the finished drug.
(viii) An explanation of the exact significance of any batch control
numbers used in the manufacturing, processing, packaging, and labeling
of the new animal drug, including such control numbers that may appear
on the label of the finished article. State whether these numbers enable
determination of the complete manufacturing history of the product.
Describe any methods used to permit determination of the distribution of
any batch if its recall is required.
(ix) Adequate information with respect to the characteristics of and
the test methods employed for the container, closure, or other component
parts of the drug package to assure their suitability for the intended
use.
(x) A complete description of, and data derived from, studies of the
stability of the new animal drug in the final dosage form, including
information showing the suitability of the analytical methods used. A
description of
[[Page 58]]
any additional stability studies underway or planned. Stability data for
the finished dosage form of the new animal drug in the container in
which it is to be marketed, including any proposed multiple dose
container, and, if it is to be put into solution at the time of
dispensing, for the solution prepared as directed. If the new animal
drug is intended for use in the manufacture of Type C medicated feed as
defined in Sec. 558.3 of this chapter, stability data derived from
studies in which representative formulations of the medicated feed
articles are used. Similar data may be required for Type B medicated
feeds as determined by the Food and Drug Administration on a case-by-
case basis. Expiration dates shall be proposed for finished
pharmaceutical dosage forms and Type A medicated articles. If the data
indicate that an expiration date is needed for Type B or Type C
medicated feeds, the applicant shall propose such expiration date. If no
expiration date is proposed for Type B or Type C medicated feeds, the
applicant shall justify its absence with data.
(xi) Additional procedures employed which are designed to prevent
contamination and otherwise assure proper control of the product. An
application may be refused unless it includes adequate information
showing that the methods used in, and the facilities and controls used
for, the manufacturing, processing, and packaging of the new animal drug
are adequate to preserve its identity, strength, quality, and purity in
conformity with good manufacturing practice and identifies each
establishment, showing the location of the plant conducting these
operations.
(6) Samples. Samples of the new animal drug and articles used as
components and information concerning them may be requested by the
Center for Veterinary Medicine as follows:
(i) Each sample shall consist of four identical, separately packaged
subdivisions, each containing at least three times the amount required
to perform the laboratory test procedures described in the application
to determine compliance with its control specifications for identity and
assays. Each of the samples submitted shall be appropriately packaged
and labeled to preserve its characteristics, to identify the material
and the quantity in each subdivision of the sample, and to identify each
subdivision with the name of the applicant and the new animal drug
application to which it relates. Included are:
(a) A sample or samples of any reference standard and blank used in
the procedures described in the application for assaying each new animal
drug and other assayed components of the finished new animal drug.
(b) A representative sample or samples of each strength of the
finished dosage form proposed in the application and employed in the
clinical investigations and a representative sample or samples of each
new animal drug from the batch(es) employed in the production of such
dosage form.
(c) A representative sample or samples of finished market packages
of each strength of the dosage form of the new animal drug prepared for
initial marketing and, if any such sample is not from a representative
commercial-scale production batch, such a sample from a representative
commercial-scale production batch, and a representative sample or
samples of each new animal drug from the batch(es) employed in the
production of such dosage form, provided that in the case of new animal
drugs marketed in large packages the sample should contain only three
times a sufficient quantity of the new animal drug to allow for
performing the control tests for drug identity and assays.
(ii) The following information shall be included for the samples
when requested:
(a) For each sample submitted, full information regarding its
identity and the origin of any new animal drug contained therein
(including a statement whether it was produced on a laboratory, pilot-
plant, or full-production scale) and detailed results of all laboratory
tests made to determine the identity, strength, quality, and purity of
the batch represented by the sample, including assays.
(b) For any reference standard submitted, a complete description of
its preparation and the results of all laboratory tests on it. If the
test methods used differed from those described in the application, full
details of the
[[Page 59]]
methods employed in obtaining the reporting results.
(7) Analytical methods for residues. Applications shall include a
description of practicable methods for determining the quantity, if any,
of the new animal drug in or on food, and any substance formed in or on
food because of its use, and the proposed tolerance or withdrawal period
or other use restrictions to ensure that the proposed use of this drug
will be safe. When data or other adequate information establish that it
is not reasonable to expect the new animal drug to become a component of
food at concentrations considered unsafe, a regulatory method is not
required.
(i) The kind of information required by this subdivision may
include: Complete experimental protocols for determining drug residue
levels in the edible products, and the length of time required for
residues to be eliminated from such products following the drug's use;
residue studies conducted under appropriate (consistent with the
proposed usage) conditions of dosage, time, and route of administration
to show levels, if any, of the drug and/or its metabolites in test
animals during and upon cessation of treatment and at intervals
thereafter in order to establish a disappearance curve; if the drug is
to be used in combination with other drugs, possible effects of
interaction demonstrated by the appropriate disappearance curve or
depletion patterns after drug withdrawal under appropriate (consistent
with the proposed usage) conditions of dosage, time, and route of
administration; if the drug is given in the feed or water, appropriate
consumption records of the medicated feed or water and appropriate
performance data in the treated animal; if the drug is to be used in
more than one species, drug residue studies or appropriate metabolic
studies conducted for each species that is food-producing. To provide
these data, a sufficient number of birds or animals should be used at
each sample interval. Appropriate use of labeled compounds (e.g.
radioactive tracers), may be utilized to establish metabolism and
depletion curves. Drug residue levels ordinarily should be determined in
muscle, liver, kidney, and fat and where applicable, in skin, milk, and
eggs (yolk and egg white). As a part of the metabolic studies, levels of
the drug or metabolite should be determined in blood where feasible.
Samples may be combined where necessary. Where residues are suspected or
known to be present in litter from treated animals, it may be necessary
to include data with respect to such residues becoming components of
other agricultural commodities because of use of litter from treated
animals.
(ii) A new animal drug that has the potential to contaminate human
food with residues whose consumption could present a risk of cancer to
people must satisfy the requirements of subpart E of part 500 of this
chapter.
(8) Evidence to establish safety and effectiveness. (i) An
application may be refused unless it contains full reports of adequate
tests by all methods reasonably applicable to show whether or not the
new animal drug is safe and effective for use as suggested in the
proposed labeling.
(ii) An application may be refused unless it includes substantial
evidence of the effectiveness of the new animal drug as defined in Sec.
514.4.
(iii) An application may be refused unless it contains detailed
reports of the investigations, including studies made on laboratory
animals, in which the purpose, methods, and results obtained are clearly
set forth of acute, subacute, and chronic toxicity, and unless it
contains appropriate clinical laboratory results related to safety and
efficacy. Such information should include identification of the person
who conducted each investigation, a statement of where the
investigations were conducted, and where the raw data are available in
the application.
(iv) All information pertinent to an evaluation of the safety and
effectiveness of the new animal drug received or otherwise obtained by
the applicant from any source, including information derived from other
investigations or commercial marketing (for example, outside the United
States), or reports in the scientific literature, both favorable and
unfavorable, involving the new animal drug that is the subject of the
application and related new animal drugs shall be submitted. An adequate
summary may be acceptable in lieu of
[[Page 60]]
a reprint of a published report that only supports other data submitted.
Include any evaluation of the safety or effectiveness of the new animal
drug that has been made by the applicant's veterinary or medical
department, expert committee, or consultants.
(v) If the new animal drug is a combination of active ingredients or
animal drugs, an application may be refused unless it includes
substantial evidence of the effectiveness of the combination new animal
drug as required in Sec. 514.4.
(vi) An application shall include a complete list of the names and
post office addresses of all investigators who received the new animal
drug. This may be incorporated in whole or in part by reference to
information submitted under the provisions of Sec. 511.1 of this
chapter.
(vii) Explain any omission of reports from any investigator to whom
the investigational new animal drug has been made available. The
unexplained omission of any reports of investigations made with the new
animal drug by the applicant or submitted to him by an investigator or
the unexplained omission of any pertinent reports of investigations or
clinical experience received or otherwise obtained by the applicant from
published literature or other sources that would bias an evaluation of
the safety of the new animal drug or its effectiveness in use,
constitutes grounds for the refusal or withdrawal of the approval of an
application.
(viii) If a sponsor has transferred any obligations for the conduct
of any clinical study to a contract research organization, the
application is required to include a statement containing the name and
address of the contract research organization, identifying the clinical
study, and listing the obligations transferred. If all obligations
governing the conduct of the study have been transferred, a general
statement of this transfer--in lieu of a listing of the specific
obligations transferred--may be submitted.
(ix) If original subject records were audited or reviewed by the
sponsor in the course of monitoring any clinical study to verify the
accuracy of the case reports submitted to the sponsor, a list
identifying each clinical study so audited or reviewed.
(9) Veterinary feed directive. Three copies of a veterinary feed
directive (VFD) must be submitted in the format described under Sec.
558.6(a)(4) of this chapter.
(10) Supplemental applications. If it is a supplemental application,
full information shall be submitted on each proposed change concerning
any statement made in the approved application.
(11) Applicant's commitment. It is understood that the labeling and
advertising for the new animal drug will prescribe, recommend, or
suggest its use only under the conditions stated in the labeling which
is part of this application and if the article is a prescription new
animal drug, it is understood that any labeling which furnishes or
purports to furnish information for use or which prescribes, recommends,
or suggests a dosage for use of the new animal drug will also contain,
in the same language and emphasis, information for its use including
indications, effects, dosages, routes, methods, and frequency and
duration of administration, any relevant hazards, contraindications,
side effects, and precautions contained in the labeling which is part of
this application. It is understood that all representations in this
application apply to the drug produced until changes are made in
conformity with Sec. 514.8.
(12) Additional commitments. (i) New animal drugs as defined in
Sec. 510.3 of this chapter, intended for use in the manufacture of
animal feeds in any State will be shipped only to persons who may
receive such drugs in accordance with Sec. 510.7 of this chapter.
(ii) The methods, facilities, and controls described under item 5 of
this application conform to the current good manufacturing practice
regulations in subchapter C of this chapter.
(iii) With respect to each nonclinical laboratory study contained in
the application, either a statement that the study was conducted in
compliance with the good laboratory practice regulations set forth in
part 58 of this chapter, or, if the study was not conducted in
compliance with such regulations, a
[[Page 61]]
brief statement of the reason for the noncompliance.
(13) [Reserved]
(14) Environmental assessment. The applicant is required to submit
either a claim for categorical exclusion under Sec. 25.30 or Sec.
25.33 of this chapter or an environmental assessment under Sec. 25.40
of this chapter.
(15) Assembling and binding the application. Assemble and bind an
original and two copies of the application as follows:
(i) Bind the original or ribbon copy of the application as copy No.
1.
(ii) Bind two identical copies as copy No. 2 and copy No. 3.
(iii) Identify each front cover with the name of the applicant, new
animal drug, and the copy number.
(iv) Number each page of the application sequentially in the upper
right hand corner or in another location so that the page numbers remain
legible after the application has been bound, and organize the
application consistent with paragraphs (b) (1) through (14) of this
section. Each copy should bear the same page numbering, whether
sequential in each volume or continuous and sequential throughout the
application.
(v) Include complete labeling in each of the copies. It is suggested
that labeling be identified by date of printing or date of preparation.
(vi) Submit separate applications for each different dosage form of
the drug proposed. Repeating basic information pertinent to all dosage
forms in each application is unnecessary if reference is made to the
application containing such information. Include in each application
information applicable to the specific dosage form, such as labeling,
composition, stability data, and method of manufacture.
(vii) Submit in folders amendments, supplements, and other
correspondence sent after submission of an original application. The
front cover of these submissions should be identified with the name of
the applicant, new animal drug, copy number, and the new animal drug
application number, if known.
(c) When a new animal drug application is submitted for a new animal
drug which has a stimulant, depressant, or hallucinogenic effect on the
central nervous system, if it appears that the drug has a potential for
abuse, the Commissioner shall forward that information to the Attorney
General of the United States.
(d) Minor use applications. Applications for minor use new animal
drugs:
(1) Definitions. For the purpose of this section:
(i) Minor use means the use of: (a) New animal drugs in minor animal
species, or (b) new animal drugs in any animal species for the control
of a disease that (1) occurs infrequently or (2) occurs in limited
geographic areas.
(ii) Minor species means animals other than cattle, horses, swine,
chickens, turkeys, dogs, and cats.
(2) Animal safety, effectiveness, human food safety, and
environmental considerations. Guidance documents for the preparation and
submission of data to satisfy the requirements of section 512 of the act
regarding animal safety, effectiveness, human food safety, and
environmental considerations for new animal drugs intended for a minor
use (as defined in paragraph (d)(1)(i) of this section) are available
from the Industry Information Staff (HFV-11), Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD
20855.
(i) Animal safety and effectiveness. Where the guidance documents do
not specifically provide for a particular minor use, the Center for
Veterinary Medicine, upon request, will advise interested persons on the
effectiveness and animal safety data regarding the minor use that will
be needed to satisfy the requirements of section 512 of the act. Where
scientifically appropriate, the Center for Veterinary Medicine will
allow the use of animal models and the extrapolation of data from a
major species to a minor species to satisfy the requirements of the act.
(ii) Human food safety and environmental considerations. These
guidance documents do not specifically provide for a particular minor
use. Therefore, the Center for Veterinary Medicine will, upon request,
advise interested persons of the data that will be needed. Where
scientifically appropriate, the Center for Veterinary Medicine will
allow the extrapolation of data from a
[[Page 62]]
major species to a minor species to satisfy the requirements of the act.
[40 FR 13825, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting Sec.
514.1, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.
Sec. 514.3 Definitions.
The definition and interpretation of terms contained in this section
apply to those terms as used throughout subchapter E.
Adverse drug experience is any adverse event associated with the use
of a new animal drug, whether or not considered to be drug related, and
whether or not the new animal drug was used in accordance with the
approved labeling (i.e., used according to label directions or used in
an extralabel manner, including but not limited to different route of
administration, different species, different indications, or other than
labeled dosage). Adverse drug experience includes, but is not limited
to:
(1) An adverse event occurring in animals in the course of the use
of an animal drug product by a veterinarian or by a livestock producer
or other animal owner or caretaker.
(2) Failure of a new animal drug to produce its expected
pharmacological or clinical effect (lack of expected effectiveness).
(3) An adverse event occurring in humans from exposure during
manufacture, testing, handling, or use of a new animal drug.
ANADA is an abbreviated new animal drug application including all
amendments and supplements.
Applicant is a person or entity who owns or holds on behalf of the
owner the approval for an NADA or an ANADA, and is responsible for
compliance with applicable provisions of the act and regulations.
Increased frequency of adverse drug experience is an increased rate
of occurrence of a particular serious adverse drug event, expected or
unexpected, after appropriate adjustment for drug exposure.
NADA is a new animal drug application including all amendments and
supplements.
Nonapplicant is any person other than the applicant whose name
appears on the label and who is engaged in manufacturing, packing,
distribution, or labeling of the product.
Potential applicant means any person:
(1) Intending to investigate a new animal drug under section 512(j)
of the Federal Food, Drug, and Cosmetic Act (the act),
(2) Investigating a new animal drug under section 512(j) of the act,
(3) Intending to file a new animal drug application (NADA) or
supplemental NADA under section 512(b)(1) of the act, or
(4) Intending to file an abbreviated new animal drug application
(ANADA) under section 512(b)(2) of the act.
Presubmission conference means one or more conferences between a
potential applicant and FDA to reach a binding agreement establishing a
submission or investigational requirement.
Presubmission conference agreement means that section of the
memorandum of conference headed ``Presubmission Conference Agreement''
that records any agreement on the submission or investigational
requirement reached by a potential applicant and FDA during the
presubmission conference.
Product defect/manufacturing defect is the deviation of a
distributed product from the standards specified in the approved
application, or any significant chemical, physical, or other change, or
deterioration in the distributed drug product, including any microbial
or chemical contamination. A manufacturing defect is a product defect
caused or aggravated by a manufacturing or related process. A
manufacturing defect may occur from a single event or from deficiencies
inherent to the manufacturing process. These defects are generally
associated with product contamination, product deterioration,
manufacturing error, defective packaging, damage from disaster, or
labeling error. For example, a labeling error may include any incident
that causes a distributed product to be mistaken for, or its labeling
applied to, another product.
Serious adverse drug experience is an adverse event that is fatal,
or life-threatening, or requires professional
[[Page 63]]
intervention, or causes an abortion, or stillbirth, or infertility, or
congenital anomaly, or prolonged or permanent disability, or
disfigurement.
Unexpected adverse drug experience is an adverse event that is not
listed in the current labeling for the new animal drug and includes any
event that may be symptomatically and pathophysiologically related to an
event listed on the labeling, but differs from the event because of
greater severity or specificity. For example, under this definition
hepatic necrosis would be unexpected if the labeling referred only to
elevated hepatic enzymes or hepatitis.
[68 FR 15365, Mar. 31, 2003, as amended at 69 FR 51170, Aug. 18, 2004]
Sec. 514.4 Substantial evidence.
(a) Definition of substantial evidence. Substantial evidence means
evidence consisting of one or more adequate and well-controlled studies,
such as a study in a target species, study in laboratory animals, field
study, bioequivalence study, or an in vitro study, on the basis of which
it could fairly and reasonably be concluded by experts qualified by
scientific training and experience to evaluate the effectiveness of the
new animal drug involved that the new animal drug will have the effect
it purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling or proposed
labeling thereof. Substantial evidence shall include such adequate and
well-controlled studies that are, as a matter of sound scientific
judgment, necessary to establish that a new animal drug will have its
intended effect.
(b) Characteristics of substantial evidence--(1) Qualifications of
experts. Any study that is intended to be part of substantial evidence
of the effectiveness of a new animal drug shall be conducted by experts
qualified by scientific training and experience.
(2) Intended uses and conditions of use. Substantial evidence of
effectiveness of a new animal drug shall demonstrate that the new animal
drug is effective for each intended use and associated conditions of use
for and under which approval is sought.
(i) Dose range labeling. Sponsors should, to the extent possible,
provide for a dose range because it increases the utility of the new
animal drug by providing the user flexibility in the selection of a safe
and effective dose. In general, substantial evidence to support dose
range labeling for a new animal drug intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease must consist of at
least one adequate and well-controlled study on the basis of which
qualified experts could fairly and reasonably conclude that the new
animal drug will be effective for the intended use at the lowest dose of
the dose range suggested in the proposed labeling for that intended use.
Substantial evidence to support dose range labeling for a new animal
drug intended to affect the structure or function of the body of an
animal generally must consist of at least one adequate and well-
controlled study on the basis of which qualified experts could fairly
and reasonably conclude that the new animal drug will be effective for
the intended use at all doses within the range suggested in the proposed
labeling for the intended use.
(ii) [Reserved]
(3) Studies--(i) Number. Substantial evidence of the effectiveness
of a new animal drug for each intended use and associated conditions of
use shall consist of a sufficient number of current adequate and well-
controlled studies of sufficient quality and persuasiveness to permit
qualified experts:
(A) To determine that the parameters selected for measurement and
the measured responses reliably reflect the effectiveness of the new
animal drug;
(B) To determine that the results obtained are likely to be
repeatable, and that valid inferences can be drawn to the target animal
population; and
(C) To conclude that the new animal drug is effective for the
intended use at the dose or dose range and associated conditions of use
prescribed, recommended, or suggested in the proposed labeling.
(ii) Types. Adequate and well-controlled studies that are intended
to provide substantial evidence of the effectiveness of a new animal
drug may include, but are not limited to, published studies, foreign
studies, studies
[[Page 64]]
using models, and studies conducted by or on behalf of the sponsor.
Studies using models shall be validated to establish an adequate
relationship of parameters measured and effects observed in the model
with one or more significant effects of treatment.
(c) Substantial evidence for combination new animal drugs--(1)
Definitions. The following definitions of terms apply to this section:
(i) Combination new animal drug means a new animal drug that
contains more than one active ingredient or animal drug that is applied
or administered simultaneously in a single dosage form or simultaneously
in or on animal feed or drinking water.
(ii) Dosage form combination new animal drug means a combination new
animal drug intended for use other than in animal feed or drinking
water.
(iii) Antibacterial with respect to a particular target animal
species means an active ingredient or animal drug: That is approved in
that species for the diagnosis, cure, mitigation, treatment, or
prevention of bacterial disease; or that is approved for use in that
species for any other use that is attributable to its antibacterial
properties. But, antibacterial does not include ionophores or arsenicals
intended for use in combination in animal feed or drinking water.
(iv) Appropriate concurrent use exists when there is credible
evidence that the conditions for which the combination new animal drug
is intended can occur simultaneously.
(2) Combination new animal drugs that contain only active
ingredients or animal drugs that have previously been separately
approved.
(i) For dosage form combination new animal drugs, except for those
that contain a nontopical antibacterial, that contain only active
ingredients or animal drugs that have previously been separately
approved for the particular uses and conditions of use for which they
are intended in combination, a sponsor shall demonstrate:
(A) By substantial evidence, as defined in this section, that any
active ingredient or animal drug intended only for the same use as
another active ingredient or animal drug in the combination makes a
contribution to the effectiveness of the combination new animal drug;
(B) That each active ingredient or animal drug intended for at least
one use that is different from all the other active ingredients or
animal drugs used in the combination provides appropriate concurrent use
for the intended target animal population; and
(C) That the active ingredients or animal drugs are physically
compatible and do not have disparate dosing regimens if FDA, based on
scientific information, has reason to believe the active ingredients or
animal drugs are physically incompatible or have disparate dosing
regimens.
(ii) For combination new animal drugs intended for use in animal
feed or drinking water that contain only active ingredients or animal
drugs that have previously been separately approved for the particular
uses and conditions of use for which they are intended in combination,
the sponsor shall demonstrate:
(A) By substantial evidence, as defined in this section, that any
active ingredient or animal drug intended only for the same use as
another active ingredient or animal drug in the combination makes a
contribution to the effectiveness of the combination new animal drug;
(B) For such combination new animal drugs that contain more than one
antibacterial ingredient or animal drug, by substantial evidence, as
defined in this section, that each antibacterial makes a contribution to
labeled effectiveness;
(C) That each active ingredient or animal drug intended for at least
one use that is different from all other active ingredients or animal
drugs used in the combination provides appropriate concurrent use for
the intended target animal population; and
(D) That the active ingredients or animal drugs intended for use in
drinking water are physically compatible if FDA, based on scientific
information, has reason to believe the active ingredients or animal
drugs are physically incompatible.
(3) Other combination new animal drugs. For all other combination
new
[[Page 65]]
animal drugs, the sponsor shall demonstrate by substantial evidence, as
defined in this section, that the combination new animal drug will have
the effect it purports or is represented to have under the conditions of
use prescribed, recommended, or suggested in the proposed labeling and
that each active ingredient or animal drug contributes to the
effectiveness of the combination new animal drug.
[64 FR 40756, July 28, 1999]
Sec. 514.5 Presubmission conferences.
(a) General principle underlying the conduct of a presubmission
conference. The general principle underlying the conduct of any
presubmission conference is that there should be candid, full, and open
communication.
(b) Requesting a presubmission conference. A potential applicant is
entitled to one or more conferences prior to the submission of an NADA,
supplemental NADA, or an ANADA to reach an agreement establishing part
or all of a submission or investigational requirement. A potential
applicant's request for a presubmission conference must be submitted to
FDA in a signed letter. The letter must include a proposed agenda that
clearly outlines the scope, purpose, and objectives of the presubmission
conference and must list the names and positions of the representatives
who are expected to attend the presubmission conference on behalf of the
applicant.
(c) Timing. A potential applicant may request one or more
presubmission conferences at any time prior to the filing of a NADA,
supplemental NADA, or an ANADA. A request for a presubmission conference
must be received by FDA at least 30 calendar days in advance of the
requested conference date. FDA will schedule the presubmission
conference at a time agreeable to both FDA and the potential applicant.
(d) Advance information. The potential applicant must provide to
FDA, at least 30 calendar days before a scheduled presubmission
conference, a detailed agenda, a copy of any materials to be presented
at the conference, a list of proposed indications and, if available, a
copy of the proposed labeling for the product under consideration, and
copies of materials evaluated or referenced relative to issues listed in
the agenda for the conference. If the materials are not provided or are
not sufficient to provide the basis for meaningful discussion, FDA may
elect to postpone part or all of the meeting until sufficient materials
are provided to FDA.
(e) Conduct of a presubmission conference. The potential applicant
and FDA may each bring consultants to the presubmission conference. The
presubmission conference(s) will be directed primarily at establishing
agreement between FDA and the potential applicant regarding a submission
or investigational requirement. The submission or investigational
requirement may include, among other things, the number, types, and
general design of studies that are necessary to demonstrate the safety
and effectiveness of a new animal drug for the intended uses and
conditions of use prescribed, recommended, or suggested in the proposed
labeling for the new animal drug.
(f) Documentation of a presubmission conference--(1) Memorandum of
conference--(i) Preparation. FDA will prepare a memorandum for each
presubmission conference that will include, among other things, any
background pertinent to the request for meeting; a summary of the key
points of discussion; agreements; and action items and assignments of
responsibility. That portion of the memorandum of conference that
documents any agreements reached regarding all or part of a submission
or investigational requirement will be included under the heading
``Presubmission Conference Agreement.'' If the presubmission conference
agreement section of the memorandum is silent on an issue, including one
that was discussed in the conference or addressed by materials provided
for the conference, such silence does not constitute agreement between
FDA and the potential applicant on the issue.
(ii) Sending a copy to the potential applicant. FDA will send a copy
of the memorandum to the potential applicant for review no later than 45
calendar days after the date of the conference
(iii) Requests for changes or clarification. If a potential
applicant requests
[[Page 66]]
changes to, or clarification of, the substance of the memorandum, the
request must be sent to FDA within 30 calendar days from the date a copy
of the memorandum is sent to the applicant. If the potential applicant
requests changes or clarification, FDA will send the potential applicant
a response to their request no later than 45 calendar days after the
date of receipt of the request.
(iv) Administrative record. A copy of FDA's original memorandum of
conference and, as appropriate, a copy of an amended memorandum to
correct or clarify the content of the original memorandum will be made
part of the administrative file.
(2) Field studies. If FDA requires more than one field study to
establish by substantial evidence that the new animal drug is effective
for its intended uses under the conditions of use prescribed,
recommended, or suggested in the proposed labeling, FDA will provide
written scientific justification for requiring more than one field
study. Such justification must be provided no later than 25 calendar
days after the date of the conference at which the requirement for more
than one field study is established. If FDA does not believe more than
one field study is required but the potential applicant voluntarily
proposes to conduct more than one field study, FDA will not provide such
written justification. If FDA requires one field study to be conducted
at multiple locations, FDA will provide justification for requiring
multiple locations verbally during the presubmission conference and in
writing as part of the memorandum of conference.
(g) Modification of presubmission conference agreements. An
agreement made under a presubmission conference requested under section
512(b)(3) of the act and documented in a memorandum of conference is
binding on the potential applicant and FDA and may only be modified if:
(1) FDA and the potential applicant mutually agree to modify, in
part or in whole, the agreement and such modification is documented and
provided to the potential applicant as described in paragraph (f)(1) of
this section; or
(2) FDA by written order determines that a substantiated scientific
requirement essential to the determination of safety or effectiveness of
the new animal drug appeared after the conference.
(h) When the terms of a presubmission conference agreement are not
valid--(1) A presubmission conference agreement will no longer be valid
if:
(i) The potential applicant makes to FDA, before, during, or after
the presubmission conference, any untrue statement of material fact; or
(ii) The potential applicant fails to follow any material term of
the agreement; and
(2) A presubmission conference may no longer be valid if the
potential applicant submits false or misleading data relating to a new
animal drug to FDA.
(i) Dispute resolution. FDA is committed to resolving differences
between a potential applicant and FDA reviewing divisions with respect
to requirements for the investigation of new animal drugs and for NADAs,
supplemental NADAs, and ANADAs as quickly and amicably as possible
through a cooperative exchange of information and views. When
administrative or procedural disputes arise, a potential applicant
should first attempt to resolve the matter within the appropriate review
division beginning with the individual(s) most directly assigned to the
review of the application or investigational exemption. If the dispute
cannot be resolved after such attempts, the dispute shall be evaluated
and administered in accordance with applicable regulations (21 CFR
10.75). Dispute resolution procedures may be further explained by
guidance available from the Center for Veterinary Medicine.
[69 FR 51170, Aug. 18, 2004]
Sec. 514.6 Amended applications.
The applicant may submit an amendment to an application that is
pending, including changes that may alter the conditions of use, the
labeling, safety, effectiveness, identity, strength, quality, or purity
of the drug or the adequacy of the manufacturing methods, facilities,
and controls to preserve
[[Page 67]]
them, in which case the unamended application may be considered as
withdrawn and the amended application may be considered resubmitted on
the date on which the amendment is received by the Food and Drug
Administration. The applicant will be notified of such date.
Sec. 514.7 Withdrawal of applications without prejudice.
The sponsor may withdraw his pending application from consideration
as a new animal drug application upon written notification to the Food
and Drug Administration. Such withdrawal may be made without prejudice
to a future filing. Upon resubmission, the time limitation will begin to
run from the date the resubmission is received by the Food and Drug
Administration. The original application will be retained by the Food
and Drug Administration although it is considered withdrawn. The
applicant shall be furnished a copy at cost on request.
Sec. 514.8 Supplemental new animal drug applications.
(a)(1) After a new animal drug application is approved, a
supplemental new animal drug application may propose changes. A
supplemental application may omit statements made in the approved
application concerning which no change is proposed. Each supplemental
application shall include up-to-date reports of any of the kinds of
information required by Sec. 514.80 that has not previously been
submitted. A supplemental application shall be accompanied by either a
claim for categorical exclusion under Sec. 25.30 or Sec. 25.33 of this
chapter or an environmental assessment under Sec. 25.40 of this
chapter.
(2) A supplemental new animal drug application shall be submitted
for any change beyond the variations provided for in the application,
including changes in the scale of production such as from pilot-plant to
production batch, that may alter the conditions of use, the labeling,
safety, effectiveness, identity, strength, quality, or purity of the new
animal drug, or the adequacy of the manufacturing methods, facilities,
or controls to preserve them.
(3) If it is a prescription drug, any mailing or promotional piece
used after the drug is placed on the market is labeling requiring a
supplemental application, unless:
(i) The parts of the labeling furnishing directions, warnings, and
information for use of the drug are the same in language and emphasis as
labeling approved or permitted; and
(ii) Any other parts of the labeling are consistent with and not
contrary to such approved or permitted labeling.
(4) The supplemental application shall be submitted as follows. A
communication proposing a change in a new animal drug application should
provide for any one of the following kinds of changes:
(i) Revision in labeling, such as updating information pertaining to
effects, dosages, and side effects and contraindications, which includes
information headed ``side effects,'' ``warnings,'' ``precautions,'' and
``contraindications.''
(ii) Addition of claim.
(iii) Revision in manufacturing or control procedures; for example,
changes in components, composition, method of manufacture, analytical
control procedures, package or tablet size, etc.
(iv) Change in manufacturing facilities.
(v) Provision for outside firm to participate in the preparation,
distribution, or packaging of a new animal drug (new distributor,
packer, supplier, manufacturer, etc.); one firm per submission.
Any number of changes may be submitted at any one time; but if they fall
into different categories as listed in paragraphs (a)(4) (i) through (v)
of this section, the proposed changes should be covered by separate
communications. Where, however, a change necessitates an overlap in
categories, it should be submitted in a single communication. For
example, a change in tablet potency would require other changes such as
in components, composition, and labeling and should be submitted in a
single communication.
(5) The following kinds of changes may be placed into effect without
the approval of a supplemental application, if such change is fully
described in the next periodic report required under Sec. 514.80(b)(4)
or, when such a report is
[[Page 68]]
not required, in a written communication to the Food and Drug
Administration within 60 days of the effective date of the change (this
does not apply to a change proposed because of any mixup or any
bacteriological or significant chemical, physical, or other change or
deterioration in the drug or any failure of one or more distributed
batches of the drug to meet its specifications):
(i) A different container size for solid oral dosage forms where
container and closure are of the same materials as those provided for in
the approved application.
(ii) Change in personnel not involving new facilities.
(iii) Change in equipment that does not alter the method of
manufacture of a new animal drug.
(iv) Change from one commercial batch size to another without any
change in manufacturing procedure.
(v) Change to more stringent specification without altering the
method described in the approved application.
(vi) Inclusion of additional specifications and methods without
deletion of those described in the approved application.
(vii) Alteration of specifications or methods for inactive
ingredients to bring them into compliance with new or revised
specifications or methods in an official compendium.
(viii) Initiation of a product identification coding system.
(ix) Addition to labeling of a reasonable expiration date where none
was previously used, with related conditions of drug storage when
appropriate, except when evidence shows that a significant deterioration
of the drug under marketing conditions has occurred which necessitates
the immediate submission of a report under Sec. 514.80(b)(1). The
report or written communication describing such change in labeling
should include stability data justifying the expiration date and
recommended conditions of storage.
(x) Change from paper labels to direct printing on glass or other
kinds of immediate containers without a change in text.
(6) Approval of a supplemental new animal drug application will not
be required to provide for an additional distributor to distribute a
drug which is the subject of an approved new animal drug application if
the conditions described in Sec. 514.80(b)(5)(iii) are met before
putting such a change into effect.
(b) When necessary for the safety or effectiveness of the drug, a
supplemental new animal drug application shall specify a period of time
within which the proposed change will be made.
(c) If a material change is made in the components' composition,
manufacturing methods, facilities, or controls, or in the labeling or
advertising, from the representations in an approved application for a
new animal drug (except changes conforming to the conditions set forth
in paragraph (a)(5) and (6) and/or paragraphs (d), (e), (f), and (g) of
this section), and the drug is marketed before a supplement is approved
for such change, approval of the application may be suspended or
withdrawn as provided in section 512(e) of the act.
(d) Changes of the following kinds proposed in supplemental new
animal drug applications should be placed into effect at the earliest
possible time:
(1) The addition to package labeling, promotional labeling, and
prescription drug advertising of additional warning, contraindication,
side effect, and precaution information.
(2) The deletion from package labeling, promotional labeling, and
drug advertising of false, misleading, or unsupported indications for
use or claims for effectiveness.
(3) Changes in the methods, facilities, or controls used for the
manufacture, processing, packing, or holding of the new animal drug
(other than utilization of establishments not covered by the approval
that is in effect) that give increased assurance that the drug will have
the characteristics of identity, strength, quality, and purity which it
purports or is represented to possess.
(e) The Food and Drug Administration will take no action against a
new animal drug or applicant solely because changes of the kinds
described in paragraph (d) of this section are placed into effect by the
applicant prior to his receipt of a written notice of approval of the
supplemental new animal drug application if all the following conditions
are met:
[[Page 69]]
(1) The supplemental new animal drug application providing a full
explanation of the basis for the changes has been submitted, plainly
marked on the mailing cover and on the supplement, ``Special new animal
drug application Supplement--changes being effected.''
(2) The applicant specifically informs the Food and Drug
Administration of the date on which such changes are being effected and
submits to the Administration nine printed copies of any revised
labeling to be placed in use, identified with the new animal drug
application number.
(3) All promotional labeling and all drug advertising are promptly
revised consistent with the changes made in the labeling on or within
the new animal drug package.
(f) When a supplemental new animal drug application proposes changes
only of the kinds described in paragraph (d) of this section, and the
applicant informs the Food and Drug Administration that the changes are
being put into effect, such notification will be regarded as an
agreement by the applicant to an extension of the time for formal action
on the application.
(g) In addition to changes as permitted by paragraphs (d) and (e) of
this section, an applicant may place into effect changes proposed in a
supplement to a new animal drug application that became effective prior
to October 10, 1962, upon written notification from the Food and Drug
Administration that such action is permitted, without approval of the
supplemental application, pending the completion of the review of the
effectiveness of such drug by the National Academy of Sciences-National
Research Council and a determination as to whether there are grounds for
refusing approval under section 512(d) of the act or for invoking
section 512(e) of the act. The Food and Drug Administration will take no
action against a new animal drug or an applicant solely because changes
that have been permitted in a written communication are placed into
effect by the applicant prior to his receipt of a written notice of
approval of the supplemental new animal drug application.
(h) Except as provided in paragraphs (e) and (g) of this section, no
provision of this section shall limit the authority of the Secretary or
of the Commissioner to suspend or withdraw approval of a new animal drug
application in accord with the provisions of section 512(e) of the act
or to initiate any other regulatory proceedings with respect to a drug
or applicant under provisions of the act.
(i) Changes from the conditions of an approved new animal drug
application in accord with the provisions of paragraphs (d), (e), and
(g) of this section are permitted on the basis of a temporary deferral
of final action on the supplemental application under the provisions of
section 512 (c), (d), or (e) of the act.
(j) When an applicant receives written notification from the Food
and Drug Administration, under the provisions of paragraph (g) of this
section, that he may place into effect changes proposed in a
supplemental application without approval of the supplemental
application, he may within 30 days submit a written request that the
Food and Drug Administration process the supplemental application. In
such case, the change shall not be put into effect until approved.
Within 180 days of the receipt of such written request, the Food and
Drug Administration will approve the supplemental application or furnish
notice of an opportunity for a hearing under the provisions of section
512 (d) or (e), or both, of the act on a proposal to refuse approval of
the supplemental application or to withdraw approval of the application
and supplements thereto.
(k) A supplement to an application that became effective prior to
October 10, 1962, may include a written statement to the effect that a
temporary deferral of final action under the provisions of paragraph
(d), (e), or (g) of this section is unacceptable to the applicant and
that the applicant requests action as provided in section 512(c) of the
act. Final action on such supplemental applications will be expedited in
accord with applicable provisions of section 512 of the act and
regulations in this subchapter E. In such cases, if the applicant places
into effect any of the proposed changes prior to his receipt of a
written notice of approval of
[[Page 70]]
the supplemental new animal drug application, such action may be
regarded by the Food and Drug Administration as a basis for invoking the
provisions of section 512(e)(1)(D) of the act; that is, the applicant
may be furnished notice of an opportunity for a hearing on a proposal to
withdraw approval of the application on the ground that the application
contains an untrue statement of a material fact related to the changes
from the conditions approved in the application.
(l) A supplemental application that contains nonclinical laboratory
studies shall include, with respect to each nonclinical study, either a
statement that the study was conducted in compliance with the
requirements set forth in part 58 of this chapter, or, if the study was
not conducted in compliance with such regulations, a brief statement of
the reason for the noncompliance.
[40 FR 13825, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 50
FR 16668, Apr. 26, 1985; 62 FR 40600, July 29, 1997; 68 FR 15365, Mar.
31, 2003]
Sec. 514.11 Confidentiality of data and information in a new animal drug
application file.
(a) For purposes of this section the NADA file includes all data and
information submitted with or incorporated by reference in the NADA,
INAD's incorporated into the NADA, supplemental NADA's, reports under
Sec. Sec. 514.80 and 510.301 of this chapter, master files, and other
related submissions. The availability for public disclosure of any
record in the NADA file shall be handled in accordance with the
provisions of this section.
(b) The existence of an NADA file will not be disclosed by the Food
and Drug Administration before an approval has been published in the
Federal Register, unless it has previously been publicly disclosed or
acknowledged.
(c) If the existence of an NADA file has not been publicly disclosed
or acknowledged, no data or information in the NADA file is available
for public disclosure.
(d) If the existence of an NADA file has been publicly disclosed or
acknowledged before an approval has been published in the Federal
Register, no data or information contained in the file is available for
public disclosure before such approval is published, but the
Commissioner may, in his discretion, disclose a summary of such selected
portions of the safety and effectiveness data as are appropriate for
public consideration of a specific pending issue, e.g., at an open
session of a Food and Drug Administration advisory committee or pursuant
to an exchange of important regulatory information with a foreign
government.
(e) After an approval has been published in the Federal Register,
the following data and information in the NADA file are immediately
available for public disclosure unless extraordinary circumstances are
shown:
(1) All safety and effectiveness data and information previously
disclosed to the public, as defined in Sec. 20.81 of this chapter.
(2) A summary or summaries of the safety and effectiveness data and
information submitted with or incorporated by reference in the NADA
file. Such summaries do not constitute the full reports of
investigations under section 512(b)(1) of the act (21 U.S.C. 360b(b)(1))
on which the safety or effectiveness of the drug may be approved. Such
summaries shall consist of the following:
(i) For an NADA approved prior to July 1, 1975, internal agency
records that describe such data and information, e.g., a summary of
basis for approval or internal reviews of the data and information,
after deletion of:
(a) Names and any information that would identify the investigators.
(b) Any inappropriate gratuitous comments unnecessary to an
objective analysis of the data and information.
(ii) For an NADA approved on or after July 1, 1975, a summary of
such data and information prepared in one of the following two
alternative ways shall be publicly released when the approval is
published in the Federal Register.
(a) The Center for Veterinary Medicine may at an appropriate time
prior to approval of the NADA require the applicant to prepare a summary
of such data and information, which will be reviewed and, where
appropriate, revised by the Center.
[[Page 71]]
(b) The Center for Veterinary Medicine may prepare its own summary
of such data and information.
(3) A protocol for a test or study, unless it is shown to fall
within the exemption established for trade secrets and confidential
commercial information in Sec. 20.61 of this chapter.
(4) Adverse reaction reports, product experience reports, consumer
complaints, and other similar data and information, after deletion of:
(i) Names and any information that would identify the person using
the product.
(ii) Names and any information that would identify any third party
involved with the report, such as a physician, hospital, or other
institution.
(5) A list of all active ingredients and any inactive ingredients
previously disclosed to the public as defined in Sec. 20.81 of this
chapter.
(6) An assay method or other analytical method, unless it serves no
regulatory or compliance purpose and is shown to fall within the
exemption established in Sec. 20.61 of this chapter.
(7) All correspondence and written summaries of oral discussions
relating to the NADA, in accordance with the provisions of part 20 of
this chapter.
(f) All safety and effectiveness data and information not previously
disclosed to the public are available for public disclosure at the time
any one of the following events occurs unless extraordinary
circumstances are known:
(1) The NADA has been abandoned and no further work is being
undertaken with respect to it.
(2) A final determination is made that the NADA is not approvable,
and all legal appeals have been exhausted.
(3) Approval of the NADA is withdrawn, and all legal appeals have
been exhausted.
(4) A final determination has been made that the animal drug is not
a new animal drug.
(5) A final determination has been made that the animal drug may be
marketed without submission of such safety and/or effectiveness data and
information.
(g) The following data and information in an NADA file are not
available for public disclosure unless they have been previously
disclosed to the public as defined in Sec. 20.81 of this chapter or
they relate to a product or ingredient that has been abandoned and they
no longer represent a trade secret or confidential commercial or
financial information as defined in Sec. 20.61 of this chapter:
(1) Manufacturing methods or processes, including quality control
procedures.
(2) Production, sales, distribution, and similar data and
information, except that any compilation of such data and information
aggregated and prepared in a way that does not reveal data or
information which is not available for public disclosure under this
provision is available for public disclosure.
(3) Quantitative or semiquantitative formulas.
(h) For purposes of this regulation, safety and effectiveness data
include all studies and tests of an animal drug on animals and all
studies and tests on the animal drug for identity, stability, purity,
potency, and bioavailability.
[40 FR 13825, Mar. 27, 1975, as amended at 42 FR 3109, Jan. 14, 1977; 42
FR 15675, Mar. 22, 1977; 54 FR 18280, Apr. 28, 1989; 68 FR 15365, Mar.
31, 2003]
Sec. 514.12 Confidentiality of data and information in an investigational
new animal drug notice.
(a) The existence of an INAD notice will not be disclosed by the
Food and Drug Administration unless it has previously been publicly
disclosed or acknowledged.
(b) The availability for public disclosure of all data and
information in an INAD file shall be handled in accordance with
provisions established in Sec. 514.11.
Sec. 514.15 Untrue statements in applications.
Among the reasons why an application for a new animal drug or animal
feed bearing or containing a new animal drug may contain an untrue
statement of a material fact are:
(a) Differences in:
(1) Conditions of use prescribed, recommended, or suggested by the
applicant for the product from the conditions of such use stated in the
application;
[[Page 72]]
(2) Articles used as components of the product from those listed in
the application;
(3) Composition of the product from that stated in the application;
(4) Methods used in or the facilities and controls used for the
manufacture, processing, or packing of the product from such methods,
facilities, and controls described in the application;
(5) Labeling from the specimens contained in the application; or
(b) The unexplained omission in whole or in part from an application
or from an amendment or supplement to an application or from any record
or report required under the provisions of section 512 of the act and
Sec. 514.80 or Sec. 510.301 of this chapter of any information
obtained from:
(1) Investigations as to the safety, effectiveness, identity,
strength, quality, or purity of the drug, made by the applicant on the
drug, or
(2) Investigations or experience with the product that is the
subject of the application, or any related product, available to the
applicant from any source if such information is pertinent to an
evaluation of the safety, effectiveness, identity, strength, quality, or
purity of the drug, when such omission would bias an evaluation of the
safety or effectiveness of the product.
(c) Any nonclinical laboratory study contained in the application
was not conducted in compliance with the good laboratory practice
regulations as set forth in part 58 of this chapter, and the application
fails to include a brief statement of the reason for the noncompliance.
[40 FR 13825, Mar. 27, 1975, as amended at 49 FR 7226, Feb. 28, 1984; 50
FR 7517, Feb. 22, 1985; 68 FR 15365, Mar. 31, 2003]
Subpart B_Administrative Actions on Applications
Sec. 514.80 Records and reports concerning experience with approved new
animal drugs.
The following table outlines the purpose for each paragraph of this
section:
------------------------------------------------------------------------
Purpose 21 CFR Paragraph and Title
------------------------------------------------------------------------
What information must be reported 514.80(a) Applicability.
concerning approved NADAs or ANADAs?
------------------------------------------------------------------------
What authority does FDA have for 514.80(a)(1).
requesting records and reports?
Who is required to establish, maintain,
and report required information
relating to experiences with a new
animal drug?
Is information from foreign sources
required?
------------------------------------------------------------------------
What records must be established and 514.80(a)(2).
maintained and what reports filed with
FDA?
------------------------------------------------------------------------
What is FDA's purpose for requiring 514.80(a)(3).
reports?
------------------------------------------------------------------------
Do applicants of Type A medicated 514.80(a)(4).
articles have to establish, maintain,
and report information required under
Sec. 514.80?
------------------------------------------------------------------------
How do the requirements under Sec. 514.80(a)(5).
514.80 relate to current good
manufacturing practices?
------------------------------------------------------------------------
514.80(b) Reporting
requirements.
------------------------------------------------------------------------
What are the requirements for reporting 514.80(b)(1) Three-day NADA/
product/manufacturing defects? ANADA field alert report.
------------------------------------------------------------------------
514.80(b)(2) Fifteen-day NADA/
ANADA alert report.
------------------------------------------------------------------------
What are the requirements for reporting 514.80(b)(2)(i) Initial
serious and unexpected adverse drug report.
experiences?
------------------------------------------------------------------------
What are the requirements for followup 514.80(b)(2)(ii) Followup
reporting of serious and unexpected report.
adverse drug experiences?
------------------------------------------------------------------------
What are the requirements for 514.80(b)(3) Nonapplicant
nonapplicants for reporting adverse report.
drug experiences?
------------------------------------------------------------------------
[[Page 73]]
What are the general requirements for 514.80(b)(4) Periodic drug
submission of periodic drug experience experience report.
reports, e.g., forms to be submitted,
submission date and frequency, when is
it to be submitted, how many copies?
How do I petition to change the date of
submission or frequency of submissions?
------------------------------------------------------------------------
What must be submitted in the periodic 514.80(b)(4)(i) through
drug experience reports? (b)(4)(iv).
------------------------------------------------------------------------
What distribution data must be 514.80(b)(4)(i) Distribution
submitted? data.
How should the distribution data be
submitted?
------------------------------------------------------------------------
What labeling materials should be 514.80(b)(4)(ii) Labeling.
submitted?
How do I report changes to the labeling
materials since the last report?
------------------------------------------------------------------------
514.80(b)(4)(iii) Nonclinical
laboratory studies and
clinical data not previously
reported.
------------------------------------------------------------------------
What are the requirements for submission 514.80(b)(4)(iii)(A).
of nonclinical laboratory studies?
------------------------------------------------------------------------
What are the requirements for submission 514.80(b)(4)(iii)(B).
of clinical laboratory data?
------------------------------------------------------------------------
When must results of clinical trials 514.80(b)(4)(iii)(C).
conducted by or for the applicant be
reported?
------------------------------------------------------------------------
514.80(b)(4)(iv) Adverse drug
experiences.
------------------------------------------------------------------------
How do I report product/manufacturing 514.80(b)(4)(iv)(A).
defects and adverse drug experiences
not previously reported to FDA?
------------------------------------------------------------------------
What are the requirements for submitting 514.80(b)(4)(iv)(B).
adverse drug experiences cited in
literature?
------------------------------------------------------------------------
What are the requirements for submitting 514.80(b)(4)(iv)(C).
adverse drug experiences in
postapproval studies and clinical
trials?
------------------------------------------------------------------------
What are the requirements for reporting 514.80(b)(4)(v) Summary report
increases in the frequency of serious, of increased frequency of
expected, and unexpected adverse drug adverse drug experience.
experiences?
------------------------------------------------------------------------
514.80(b)(5) Other reporting.
------------------------------------------------------------------------
Can FDA request that an applicant submit 514.80(b)(5)(i) Special drug
information at different times than experience report.
stated specifically in this regulation?
------------------------------------------------------------------------
What are the requirements for submission 514.80(b)(5)(ii)
of advertisement and promotional Advertisements and
labeling to FDA? promotional labeling.
------------------------------------------------------------------------
What are the requirements for adding a 514.80(b)(5)(iii)
new distributor to the approved Distributor's statement.
application?
------------------------------------------------------------------------
What labels and how many labels need to 514.80(b)(5)(iii)(A).
be submitted for review?
------------------------------------------------------------------------
What changes are required and allowed to 514.80(b)(5)(iii)(A)(1).
distributor labeling?
------------------------------------------------------------------------
What are the requirements for making 514.80(b)(5)(iii)(A)(2).
other changes to the distributor
labeling?
------------------------------------------------------------------------
What information should be included in 514.80(b)(5)(iii)(B)(1)
each new distributor's signed through (b)(5)(iii)(B)(5).
statement?
------------------------------------------------------------------------
What are the conditions for submitting 514.80(c) Multiple
information that is common to more than applications.
one application? (i.e., can I submit
common information to one application?)
------------------------------------------------------------------------
What information has to be submitted to 514.80(c)(1) through (c)(4).
the common application and related
application?
------------------------------------------------------------------------
What forms do I need? 514.80(d) Reporting forms.
What are Forms FDA 1932 and 2301?
How can I get them?
Can I use computer-generated
equivalents?
------------------------------------------------------------------------
[[Page 74]]
How long must I maintain Form FDA 1932 514.80(e) Records to be
and records and reports of other maintained.
required information, i.e., how long do
I need to maintain this information?
------------------------------------------------------------------------
What are the requirements for allowing 514.80(f) Access to records
access to these records and reports, and reports.
and copying by authorized FDA officer
or employee?
------------------------------------------------------------------------
How do I obtain Forms FDA 1932 and 2301? 514.80(g) Mailing addresses.
Where do I mail FDA's required forms,
records, and reports?
------------------------------------------------------------------------
What happens if the applicant fails to 514.80(h) Withdrawal of
establish, maintain, or make the approval.
required reports?
What happens if the applicant refuses to
allow FDA access to, and/or copying and/
or verify records and reports?
------------------------------------------------------------------------
Does an adverse drug experience reflect 514.80(i) Disclaimer.
a conclusion that the report or
information constitutes an admission
that the drug caused an adverse effect?
------------------------------------------------------------------------
(a) Applicability. (1) Each applicant must establish and maintain
indexed and complete files containing full records of all information
pertinent to safety or effectiveness of a new animal drug that has not
been previously submitted as part of the NADA or ANADA. Such records
must include information from domestic as well as foreign sources. Each
nonapplicant must establish and maintain indexed and complete files
containing full records of all information pertinent to safety or
effectiveness of a new animal drug that is received or otherwise
obtained by the nonapplicant. Such records must include information from
domestic as well as foreign sources.
(2) Each applicant must submit reports of data, studies, and other
information concerning experience with new animal drugs to the Food and
Drug Administration (FDA) for each approved NADA and ANADA, as required
in this section. A nonapplicant must submit data, studies, and other
information concerning experience with new animal drugs to the
appropriate applicant, as required in this section. The applicant, in
turn, must report the nonapplicant's data, studies, and other
information to FDA. Applicants and nonapplicants must submit data,
studies, and other information described in this section from domestic,
as well as foreign sources.
(3) FDA reviews the records and reports required in this section to
facilitate a determination under section 512(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b(e)) as to whether there may be
grounds for suspending or withdrawing approval of the NADA or ANADA.
(4) The requirements of this section also apply to any approved Type
A medicated article. In addition, the requirements contained in Sec.
514.80(b)(1), (b)(2), (b)(4)(iv), and (b)(4)(v) apply to any approved
Type A medicated article incorporated in animal feeds.
(5) The records and reports referred to in this section are in
addition to those required by the current good manufacturing practice
regulations in parts 211, 225, and 226 of this chapter.
(b) Reporting requirements--(1) Three-day NADA/ANADA field alert
report. This report provides information pertaining to product and
manufacturing defects that may result in serious adverse drug events.
The applicant (or nonapplicant through the applicant) must submit the
report to the appropriate FDA District Office or local FDA resident post
within 3 working days of first becoming aware that a defect may exist.
The information initially may be provided by telephone or other
telecommunication means, with prompt written followup using Form FDA
1932 ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product
Defect Report.'' The mailing cover for these reports must be plainly
marked ``3-Day NADA/ANADA Field Alert Report.''
(2) Fifteen-day NADA/ANADA alert report--(i) Initial report. This
report provides information on each serious, unexpected adverse drug
event, regardless of the source of the information. The
[[Page 75]]
applicant (or nonapplicant through the applicant) must submit the report
to FDA within 15 working days of first receiving the information. The
report must be submitted on Form FDA 1932, and its mailing cover must be
plainly marked ``15-Day NADA/ANADA Alert Report.''
(ii) Followup report. The applicant must promptly investigate all
adverse drug events that are the subject of 15-day NADA/ANADA alert
reports. If this investigation reveals significant new information, a
followup report must be submitted within 15 working days of receiving
such information. A followup report must be submitted on Form FDA 1932,
and its mailing cover must be plainly marked ``15-Day NADA/ANADA Alert
Report Followup.'' The followup report must state the date of the
initial report and provide the additional information. If additional
information is sought but not obtained within 3 months of the initial
report, a followup report is required describing the steps taken and why
additional information was not obtained.
(3) Nonapplicant report. Nonapplicants must forward reports of
adverse drug experiences to the applicant within 3 working days of first
receiving the information. The applicant must then submit the report(s)
to FDA as required in this section. The nonapplicant must maintain
records of all nonapplicant reports, including the date the nonapplicant
received the information concerning adverse drug experiences, the name
and address of the applicant, and a copy of the adverse drug experience
report including the date such report was submitted to the applicant. If
the nonapplicant elects to also report directly to FDA, the nonapplicant
should submit the report on Form FDA 1932 within 15 working days of
first receiving the information.
(4) Periodic drug experience report. This report must be accompanied
by a completed Form FDA 2301 ``Transmittal of Periodic Reports and
Promotional Materials for New Animal Drugs.'' It must be submitted every
6 months for the first 2 years following approval of an NADA or ANADA
and yearly thereafter. Reports required by this section must contain
data and information for the full reporting period. The 6-month periodic
drug experience reports must be submitted within 30 days following the
end of the 6-month reporting period. The yearly periodic drug experience
reports must be submitted within 60 days of the anniversary date of the
approval of the NADA or ANADA. Any previously submitted information
contained in the report must be identified as such. For yearly (annual)
periodic drug experience reports, the applicant may petition FDA to
change the date of submission or frequency of reporting, and after
approval of such petition, file such reports on the new filing date or
at the new reporting frequency. Also, FDA may require a report at
different times or more frequently. The periodic drug experience report
must contain the following:
(i) Distribution data. Information about the distribution of each
new animal drug product, including information on any distributor-
labeled product. This information must include the total number of
distributed units of each size, strength, or potency (e.g., 100,000
bottles of 100 5-milligram tablets; 50,000 10-milliliter vials of 5-
percent solution). This information must be presented in two categories:
Quantities distributed domestically and quantities exported.
(ii) Labeling. Applicant and distributor current package labeling,
including package inserts (if any). For large-size package labeling or
large shipping cartons, a representative copy must be submitted (e.g., a
photocopy of pertinent areas of large feed bags). A summary of any
changes in labeling made since the last report (listed by date of
implementation) must be included with the labeling or if there have been
no changes, a statement of such fact must be included with the labeling.
(iii) Nonclinical laboratory studies and clinical data not
previously reported.
(A) Copies of in vitro studies (e.g., mutagenicity) and other
nonclinical laboratory studies conducted by or otherwise obtained by the
applicant.
(B) Copies of published clinical trials of the new animal drug (or
abstracts of them) including clinical trials on safety and
effectiveness, clinical trials on
[[Page 76]]
new uses, and reports of clinical experience pertinent to safety
conducted by or otherwise obtained by the applicant. Review articles,
papers, and abstracts in which the drug is used as a research tool,
promotional articles, press clippings, and papers that do not contain
tabulations or summaries of original data are not required to be
reported.
(C) Descriptions of completed clinical trials conducted by or for
the applicant must be submitted no later than 1 year after completion of
research. Supporting information is not to be reported.
(iv) Adverse drug experiences. (A) Product/manufacturing defects and
adverse drug experiences not previously reported under Sec.
514.80(b)(1) and (b)(2) must be reported individually on Form FDA 1932.
(B) Reports of adverse drug experiences in the literature must be
noted in the periodic drug experience report. A bibliography of
pertinent references must be included with the report. Upon FDA's
request, the applicant must provide a full text copy of these
publications.
(C) Reports of previously not reported adverse drug experiences that
occur in postapproval studies must be reported separately from other
experiences in the periodic drug experience report and clearly marked or
highlighted.
(v) Summary report of increased frequency of adverse drug
experience. The applicant must periodically review the incidence of
reports of adverse drug experiences to determine if there has been an
increased frequency of serious (expected and unexpected) adverse drug
events. The applicant must evaluate the increased frequency of serious
(expected or unexpected) adverse drug events at least as often as
reporting of periodic drug experience reports. The applicant must report
the increased frequency of serious (expected and unexpected) adverse
drug events in the periodic drug experience report. Summaries of reports
of increased frequency of adverse drug events must be submitted in
narrative form. The summaries must state the time period on which the
increased frequency is based, time period comparisons in determining
increased frequency, references to any previously submitted Form FDA
1932, the method of analysis, and the interpretation of the results. The
summaries must be submitted in a separate section within the periodic
drug experience report.
(5) Other reporting--(i) Special drug experience report. Upon
written request, FDA may require that the applicant submit a report
required under Sec. 514.80 at different times or more frequently than
the timeframes stated in Sec. 514.80.
(ii) Advertisements and promotional labeling. The applicant must
submit at the time of initial dissemination one set of specimens of
mailing pieces and other labeling for prescription and over-the-counter
new animal drugs. For prescription new animal drugs, the applicant must
also submit one set of specimens of any advertisement at the time of
initial publication or broadcast. Mailing pieces and labeling designed
to contain product samples must be complete except that product samples
may be omitted. Each submission of promotional labeling or
advertisements must be accompanied by a completed Form FDA 2301.
(iii) Distributor's statement. At the time of initial distribution
of a new animal drug product by a distributor, the applicant must submit
a special drug experience report accompanied by a completed Form FDA
2301 containing the following:
(A) The distributor's current product labeling.
(1) The distributor's labeling must be identical to that in the
approved NADA/ANADA except for a different and suitable proprietary name
(if used) and the name and address of the distributor. The name and
address of the distributor must be preceded by an appropriate qualifying
phrase as permitted by the regulations such as ``manufactured for'' or
``distributed by.''
(2) Other labeling changes must be the subject of a supplemental
NADA or ANADA as described under Sec. 514.8.
(B) A signed statement by the distributor stating:
(1) The category of the distributor's operations (e.g., wholesale or
retail),
(2) That the distributor will distribute the new animal drug only
under the approved labeling,
[[Page 77]]
(3) That the distributor will promote the product only for use under
the conditions stated in the approved labeling,
(4) That the distributor will adhere to the records and reports
requirements of this section, and
(5) That the distributor is regularly and lawfully engaged in the
distribution or dispensing of prescription products if the product is a
prescription new animal drug.
(c) Multiple applications. Whenever an applicant is required to
submit a periodic drug experience report under the provisions of Sec.
514.80(b)(4) with respect to more than one approved NADA or ANADA for
preparations containing the same new animal drug so that the same
information is required to be reported for more than one application,
the applicant may elect to submit as a part of the report for one such
application (the primary application) all the information common to such
applications in lieu of reporting separately and repetitively on each.
If the applicant elects to do this, the applicant must do the following:
(1) State when a report applies to multiple applications and
identify all related applications for which the report is submitted by
NADA or ANADA number.
(2) Ensure that the primary application contains a list of the NADA
or ANADA numbers of all related applications.
(3) Submit a completed Form FDA 2301 to the primary application and
each related application with reference to the primary application by
NADA/ANADA number and submission date for the complete report of the
common information.
(4) All other information specific to a particular NADA/ANADA must
be included in the report for that particular NADA/ANADA.
(d) Reporting forms. Applicant must report adverse drug experiences
and product/manufacturing defects on Form FDA 1932, ``Veterinary Adverse
Drug Reaction, Lack of Effectiveness, Product Defect Report.'' Periodic
drug experience reports and special drug experience reports must be
accompanied by a completed Form FDA 2301 ``Transmittal of Periodic
Reports and Promotional Material for New Animal Drugs,'' in accordance
with directions provided on the forms. Computer-generated equivalents of
Form FDA 1932 or Form FDA 2301, approved by FDA before use, may be used.
Form FDA 1932 and Form FDA 2301 may be obtained on the Internet at
http://www.fda.gov/cvm/forms/forms.html, by telephoning the Division of
Surveillance (HFV-210), or by submitting a written request to the
following address: Food and Drug Administration, Center for Veterinary
Medicine, Division of Surveillance (HFV-210), 7500 Standish Pl.,
Rockville, MD 20855-2764.
(e) Records to be maintained. The applicants and nonapplicants must
maintain records and reports of all information required by this section
for a period of 5 years after the date of submission.
(f) Access to records and reports. The applicant and nonapplicant
must, upon request from any authorized FDA officer or employee, at all
reasonable times, permit such officer or employee to have access to copy
and to verify all such required records and reports.
(g) Mailing addresses. Completed 15-day alert reports, periodic drug
experience reports, and special drug experience reports must be
submitted to the following address: Food and Drug Administration, Center
for Veterinary Medicine, Document Control Unit (HFV-199), 7500 Standish
Pl., Rockville, MD 20855-2764. Three-day alert reports must be submitted
to the appropriate FDA district office or local FDA resident post.
Addresses for district offices and resident posts may be obtained from
the Internet at http://www.fda.gov (click on ``Contact FDA,'' then ``FDA
Field Offices'').
(h) Withdrawal of approval. If FDA finds that the applicant has
failed to establish the required records, or has failed to maintain
those records, or failed to make the required reports, or has refused
access to an authorized FDA officer or employee to copy or to verify
such records or reports, FDA may withdraw approval of the application to
which such records or reports relate. If FDA determines that withdrawal
of the approval is necessary, the agency shall give the applicant notice
and opportunity for hearing, as provided in Sec. 514.200, on the
question of
[[Page 78]]
whether to withdraw approval of the application.
(i) Disclaimer. Any report or information submitted under this
section and any release of that report or information by FDA will be
without prejudice and does not necessarily reflect a conclusion that the
report or information constitutes an admission that the drug caused or
contributed to an adverse event. A person need not admit, and may deny,
that the report or information constitutes an admission that a drug
caused or contributed to an adverse event.
[68 FR 15365, Mar. 31, 2003]
Sec. 514.100 Evaluation and comment on applications.
(a) After the filed application has been evaluated, the applicant
will be furnished written comment on any apparent deficiencies in the
application.
(b) When the description of the methods used in, and the facilities
and controls used for, the manufacture, processing, and packing of such
new animal drug appears adequate on its face, but it is not feasible to
reach a conclusion as to the safety and effectiveness of the new animal
drug solely from consideration of this description, the applicant may be
notified that an establishment inspection is required to verify their
adequacy.
(c) A request for samples of a new animal drug or any edible tissues
and byproducts of animals treated with such a drug, shall specify the
quantity deemed adequate to permit tests of analytical methods to
determine their adequacy for regulatory purposes. The request should be
made as early in the 180-day period as possible to assure timely
completion. The date used for computing the 180-day limit for the
purposes of section 512(c) of the act shall be moved forward 1 day for
each day after the mailing date of the request until all of the
requested samples are received. If the samples are not received within
90 days after the request, the application will be considered withdrawn
without prejudice.
(d) The information contained in an application may be insufficient
to determine whether a new animal drug is safe or effective in use if it
fails to include (among other things) a statement showing whether such
drug is to be limited to prescription sale and exempt under section
502(f) of the act from the requirement that its labeling bear adequate
directions for lay use. If such drug is to be exempt, the information
may also be insufficient if:
(1) The specimen labeling proposed fails to bear adequate
information for professional use including indications, effects,
dosages, routes, methods, and frequency and duration of administration
and any relevant hazards, contraindications, side effects, and
precautions under which practitioners licensed by law to administer such
drug can use the drug for the purposes for which it is intended,
including all purposes for which it is to be advertised, or represented,
in accordance with Sec. 201.105 of this chapter, and information
concerning hazards, contraindications, side effects, and precautions
relevant with respect to any uses for which such drug is to be
prescribed.
(2) The application fails to show that the labeling and advertising
of such drug will offer the drug for use only under those conditions for
which it is offered in the labeling that is part of the application.
(3) The application fails to show that all labeling that furnishes
or purports to furnish information for professional use of such drug
will contain, in the same language and emphasis, the information for use
including indications, effects, dosages, routes, methods, and frequency
and duration of administration and any relevant warnings, hazards,
contraindications, side effects, and precautions, which is contained in
the labeling that is part of the application in accordance with Sec.
201.105 of this chapter.
(e) The information contained in an application will be considered
insufficient to determine whether a new animal drug is safe and
effective for use when there is a refusal or failure upon written notice
to furnish inspectors authorized by the Food and Drug Administration an
adequate opportunity to inspect the facilities, controls, and records
pertinent to the application.
(f) On the basis of preliminary consideration of an application or
supplemental application containing typewritten or other draft labeling
in lieu
[[Page 79]]
of final printed labeling, an applicant may be informed that such
application is approvable when satisfactory final printed labeling
identical in content to such draft copy is submitted.
(g) When an application has been found incomplete on the basis of a
need for the kind of information described in Sec. 514.6, such
application shall be considered withdrawn without prejudice to future
filing on the date of issuance of the letter citing the inadequacies
contained in the application, unless within 30 days the sponsor chooses
to avail himself of the opportunity for hearing as prescribed by Sec.
514.111.
Sec. 514.105 Approval of applications.
(a) The Commissioner shall forward for publication in the Federal
Register a regulation prescribing the conditions under which the new
animal drug may be used, including the name and address of the
applicant; the conditions and indications for use covered by the
application; any tolerance, withdrawal period, or other use
restrictions; any tolerance required for the new animal drug substance
or its metabolites in edible products of food-producing animals; and, if
such new animal drug is intended for use in animal feed, appropriate
purposes and conditions of use (including special labeling requirements)
applicable to any animal feed; and such other information the
Commissioner deems necessary to assure safe and effective use.
(b) He shall notify the applicant by sending him a copy of the
proposed publication as described in paragraph (a)(1) of this section.
[40 FR 13825, Mar. 27, 1975, as amended at 51 FR 7392, Mar. 3, 1986; 64
FR 63203, Nov. 19, 1999]
Sec. 514.106 Approval of supplemental applications.
(a) Within 180 days after a supplement to an approved application is
filed pursuant to Sec. 514.8, the Commissioner shall approve the
supplemental application in accordance with procedures set forth in
Sec. 514.105(a)(1) and (2) if he/she determines that the application
satisfies the requirements of applicable statutory provisions and
regulations.
(b) The Commissioner will assign a supplemental application to its
proper category to ensure processing of the application.
(1) Category I. Supplements that ordinarily do not require a
reevaluation of any of the safety or effectiveness data in the parent
application. Category I supplements include the following:
(i) A corporate change that alters the identity or address of the
sponsor of the new animal drug application (NADA).
(ii) The sale, purchase, or construction of manufacturing
facilities.
(iii) The sale or purchase of an NADA.
(iv) A change in container, container style, shape, size, or
components.
(v) A change in approved labeling (color, style, format, addition,
deletion, or revision of certain statements, e.g., trade name, storage,
expiration dates, etc).
(vi) A change in promotional material for a prescription drug not
exempted by Sec. 514.8(a)(3)(i) and (a)(3)(ii).
(vii) Changes in manufacturing processes that do not alter the
method of manufacture or change the final dosage form.
(viii) A change in bulk drug shipments.
(ix) A change in an analytical method or control procedures that do
not alter the approved standards.
(x) A change in an expiration date.
(xi) Addition of an alternate manufacturer, repackager, or relabeler
of the drug product.
(xii) Addition of an alternate supplier of the new drug substance.
(xiii) A change permitted in advance of approval as listed in Sec.
514.8(d).
(xiv) Changes not requiring prior approval which are listed under
Sec. 514.8(a)(5) when submitted as supplemental applications.
(2) Category II. Supplements that may require a reevaluation of
certain safety or effectiveness data in the parent application. Category
II supplements include the following:
(i) A change in the active ingredient concentration or composition
of the final product.
(ii) A change in quality, purity, strength, and identity
specifications of the active or inactive ingredients.
[[Page 80]]
(iii) A change in dose (amount of drug administered per dose).
(iv) A change in the treatment regimen (schedule of dosing).
(v) Addition of a new therapeutic claim to the approved uses of the
product.
(vi) Addition of a new or revised animal production claim.
(vii) Addition of a new species.
(viii) A change in the prescription or over-the-counter status of a
drug product.
(ix) A change in statements regarding side effects, warnings,
precautions, and contraindications, except the addition of approved
statements to container, package, and promotional labeling, and
prescription drug advertising.
(x) A change in the drug withdrawal period prior to slaughter or in
the milk discard time.
(xi) A change in the tolerance for drug residues.
(xii) A change in analytical methods for drug residues.
(xiii) A revised method of synthesis or fermentation of the new drug
substance.
(xiv) Updating or changes in the manufacturing process of the new
drug substance and/or final dosage form (other than a change in
equipment that does not alter the method of manufacture of a new animal
drug, or a change from one commercial batch size to another without any
change in manufacturing procedure), or changes in the methods,
facilities, or controls used for the manufacture, processing, packaging,
or holding of the new animal drug (other than use of an establishment
not covered by the approval that is in effect) that give increased
assurance that the drug will have the characteristics of identity,
strength, quality, and purity which it purports or is represented to
possess.
[55 FR 46052, Nov. 1, 1990; 55 FR 49973, Dec. 3, 1990; 56 FR 12422, Mar.
25, 1991]
Sec. 514.110 Reasons for refusing to file applications.
(a) The date of receipt of an application for a new animal drug
shall be the date on which the application shall be deemed to be filed.
(b) An application for a new animal drug shall not be considered
acceptable for filing for any of the following reasons:
(1) It does not contain complete and accurate English translations
of any pertinent part in a foreign language.
(2) Fewer than three copies are submitted.
(3) It is incomplete on its face in that it is not properly
organized and indexed.
(4) On its face the information concerning required matter is so
inadequate that the application is clearly not approvable.
(5) The new animal drug is to be manufactured, prepared, propagated,
compounded, or processed in whole or in part in any State in an
establishment that has not been registered or exempted from registration
under the provisions of section 510 of the act.
(6) The sponsor does not reside or maintain a place of business
within the United States and the application has not been countersigned
by an attorney, agent, or other representative of the applicant, which
representative resides in the United States and has been duly authorized
to act on behalf of the applicant and to receive communications on all
matters pertaining to the application.
(7) The new animal drug is a drug subject to licensing under the
animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21
U.S.C. 151 et seq. ). Such applications will be referred to the U.S.
Department of Agriculture for action.
(8) It fails to include, with respect to each nonclinical laboratory
study contained in the application, either a statement that the study
was conducted in compliance with the good laboratory practice
regulations set forth in part 58 of this chapter, or, if the study was
not conducted in compliance with such regulations, a brief statement of
the reasons for the noncompliance.
(9) [Reserved]
(10) The applicant fails to submit a complete environmental
assessment under Sec. 25.40 of this chapter or fails to provide
sufficient information to establish that the requested action is subject
to categorical exclusion under Sec. 25.30 or Sec. 25.33 of this
chapter.
[[Page 81]]
(c) If an application is determined not to be acceptable for filing,
the applicant shall be notified within 30 days of receipt of the
application and shall be given the reasons therefore.
(d) If the applicant disputes the findings that his application is
not acceptable for filing, he may make written request that the
application be filed over protest, in which case it will be filed as of
the day originally received.
[40 FR 13825, Mar. 27, l975, as amended at 50 FR 7517, Feb. 22, 1985; 50
FR 16668, Apr. 26, 1985; 62 FR 40600, July 29, 1997]
Sec. 514.111 Refusal to approve an application.
(a) The Commissioner shall, within 180 days after the filing of the
application, inform the applicant in writing of his intention to issue a
notice of opportunity for a hearing on a proposal to refuse to approve
the application, if the Commissioner determines upon the basis of the
application, or upon the basis of other information before him with
respect to a new animal drug, that:
(1) The reports of investigations required to be submitted pursuant
to section 512(b) of the act do not include adequate tests by all
methods reasonably applicable to show whether or not such drug is safe
for use under the conditions prescribed, recommended, or suggested in
the proposed labeling thereof; or
(2) The results of such tests show that such drug is unsafe for use
under such conditions or do not show that such drug is safe for use
under such conditions; or
(3) The methods used in and the facilities and controls used for the
manufacture, processing, and packing of such drug are inadequate to
preserve its identity, strength, quality, and purity; or
(4) Upon the basis of the information submitted to the Food and Drug
Administration as part of the application, or upon the basis of any
other information before it with respect to such drug, it has
insufficient information to determine whether such drug is safe for use
under such conditions. In making this determination the Commissioner
shall consider, among other relevant factors:
(i) The probable consumption of such drug and of any substance
formed in or on food because of the use of such drug;
(ii) The cumulative effect on man or animal of such drug, taking
into account any chemically or pharmacologically related substances;
(iii) Safety factors which, in the opinion of experts qualified by
scientific training and experience to evaluate the safety of such drugs,
are appropriate for the use of animal experimentation data; and
(iv) Whether the conditions of use prescribed, recommended, or
suggested in the proposed labeling are reasonably certain to be followed
in practice; or
(5) Evaluated on the basis of information submitted as part of the
application and any other information before the Food and Drug
Administration with respect to such drug, there is lack of substantial
evidence as defined in Sec. 514.4.
(6) Failure to include an appropriate proposed tolerance for
residues in edible products derived from animals or a withdrawal period
or other restrictions for use of such drug if any tolerance or
withdrawal period or other restrictions for use are required in order to
assure that the edible products derived from animals treated with such
drug will be safe.
(7) Based on a fair evaluation of all material facts, the labeling
is false or misleading in any particular; or
(8) Such drug induces cancer when ingested by man or animal or,
after appropriate tests for evaluation of the safety of such drug,
induces cancer in man or animal, except that this subparagraph shall not
apply with respect to such drug if the Commissioner finds that, under
the conditions of use specified in proposed labeling and reasonably
certain to be followed in practice:
(i) Such drug will not adversely affect the animal for which it is
intended; and
(ii) No residue of such drug will be found (by methods of
examination prescribed or approved by the Commissioner by regulations)
in any edible portion of such animal after slaughter or in any food
yielded by, or derived from the living animals.
(9) The applicant fails to submit an adequate environmental
assessment
[[Page 82]]
under Sec. 25.40 of this chapter or fails to provide sufficient
information to establish that the requested action is subject to
categorical exclusion under Sec. 25.30 or Sec. 25.33 of this chapter.
(10) The drug fails to satisfy the requirements of subpart E of part
500 of this chapter.
(11) Any nonclinical laboratory study that is described in the
application and that is essential to show that the drug is safe for use
under the conditions prescribed, recommended, or suggested in its
proposed labeling, was not conducted in compliance with the good
laboratory practice regulations as set forth in part 58 of this chapter
and no reason for the noncompliance is provided or, if it is, the
differences between the practices used in conducting the study and the
good laboratory practice regulations do not support the validity of the
study.
(b) The Commissioner, as provided in Sec. 514.200 of this chapter,
shall expeditiously notify the applicant of an opportunity for a hearing
on the question of whether such application is approvable, unless by the
30th day following the date of issuance of the letter informing the
applicant of the intention to issue a notice of opportunity for a
hearing the applicant:
(1) Withdraws the application; or
(2) Waives the opportunity for a hearing; or
(3) Agrees with the Commissioner on an additional period to precede
issuance of such notice of hearing.
[40 FR 13825, Mar. 27, 1975, as amended at 43 FR 22675, May 26, 1978; 44
FR 16007, Mar. 16, 1979; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, Apr.
26, 1985; 52 FR 49588, Dec. 31, 1987; 54 FR 18280, Apr. 28, 1989; 62 FR
40600, July 29, 1997; 63 FR 10770, Mar. 5, 1998; 64 FR 40757, July 28,
1999; 64 FR 63204, Nov. 19, 1999]
Sec. 514.115 Withdrawal of approval of applications.
(a) The Secretary may suspend approval of an application approved
pursuant to section 512(c) of the act and give the applicant prompt
notice of his action and afford the applicant the opportunity for an
expedited hearing on a finding that there is an imminent hazard to the
health of man or of the animals for which such new animal drug or animal
feed is intended.
(b) The Commissioner shall notify in writing the person holding an
application approved pursuant to section 512(c) of the act and afford an
opportunity for a hearing on a proposal to withdraw approval of such
application if he finds:
(1) That the application contains any untrue statement of a material
fact; or
(2) That the applicant has made any changes from the standpoint of
safety or effectiveness beyond the variations provided for in the
application unless he has supplemented the application by filing with
the Secretary adequate information respecting all such changes and
unless there is in effect an approval of the supplemental application,
or such changes are those for which written authorization or approval is
not required as provided for in Sec. 514.8. The supplemental
application shall be treated in the same manner as the original
application.
(3) That in the case of an application for use of a new animal drug
approved or deemed approved pursuant to section 512(c) of the act:
(i) Experience or scientific data show that such drug is unsafe for
use under the conditions of use upon the basis of which the application
was approved; or
(ii) New evidence not contained in such application or not available
to the Secretary until after such application was approved, or tests by
new methods, or tests by methods not deemed reasonably applicable when
such application was approved, evaluated together with the evidence
available to the Secretary when the application was approved, shows that
such drug is not shown to be safe for use under the conditions of use
upon the basis of which the application was approved or that section 512
(d)(1)(H) of the act applies to such drug; or
(iii) On the basis of new information before him with respect to
such drug, evaluated together with the evidence available to him when
the application was approved, there is a lack of substantial evidence
that such drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or suggested
in the labeling thereof.
[[Page 83]]
(4) That any nonclinical laboratory study that is described in the
application and that is essential to show that the drug is safe for use
under the conditions prescribed, recommended, or suggested in its
proposed labeling, was not conducted in compliance with the good
laboratory practice regulations as set forth in part 58 of this chapter
and no reason for the noncompliance is provided or, if it is, the
differences between the practices used in conducting the study and the
good laboratory practice regulations do not support the validity of the
study.
(c) The Commissioner may notify in writing the person holding an
application approved pursuant to section 512(c) of the act and afford an
opportunity for a hearing on a proposal to withdraw approval of such
application if he finds:
(1) That the applicant has failed to establish a system for
maintaining required records, or has repeatedly or deliberately failed
to maintain such records or to make required reports in accordance with
a regulation or order under section 512(l)(1) of the act, or the
applicant has refused to permit access to, or copying, or verification
of, such records as required by section 512(l)(2) of the act; or
(2) That on the basis of new information before him evaluated
together with the evidence before him when the application was approved,
the methods used in, or the facilities and controls used for, the
manufacture, processing, and packing of such drug or animal feed are
inadequate to assure and preserve its identity, strength, quality, and
purity and were not made adequate within a reasonable time after receipt
of written notice from the Secretary specifying the matter complained
of; or
(3) That on the basis of new information before him, evaluated
together with the evidence before him when the application was approved,
the labeling of such drug, based on a fair evaluation of all material
facts, is false or misleading in any particular and was not corrected
within a reasonable time after receipt of written notice from the
Secretary specifying the matter complained of.
(d) Approval of an application pursuant to section 512(c) of the act
will be withdrawn on the basis of a request for its withdrawal submitted
in writing by a person holding an approved new animal drug application
on the grounds that the drug subject to such application is no longer
being marketed and information is included in support of this finding,
provided none of the conditions cited in paragraphs (a), (b), and (c) of
this section pertain to the subject drug. A written request for such
withdrawal shall be construed as a waiver of the opportunity for a
hearing as otherwise provided for in this section. Withdrawal of
approval of an application under the provisions of this paragraph shall
be without prejudice.
(e) On the basis of the withdrawal of approval of an application for
a new animal drug approved pursuant to section 512(c) of the act, the
regulation published pursuant to section 512(i) of the act covering the
conditions of use of such drug as provided for in the application shall
be revoked.
[40 FR 13825, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 64
FR 63204, Nov. 19, 1999]
Sec. 514.116 Notice of withdrawal of approval of application.
When an approval of an application submitted pursuant to section 512
of the act is withdrawn by the Commissioner, he will give appropriate
public notice of such action by publication in the Federal Register.
Sec. 514.117 Adequate and well-controlled studies.
(a) Purpose. The primary purpose of conducting adequate and well-
controlled studies of a new animal drug is to distinguish the effect of
the new animal drug from other influences, such as spontaneous change in
the course of the disease, normal animal production performance, or
biased observation. One or more adequate and well-controlled studies are
required to establish, by substantial evidence, that a new animal drug
is effective. The characteristics described in paragraph (b) of this
section have been developed over a period of years and are generally
recognized as the essentials of an adequate and well-controlled study.
Well controlled, as used in the phrase adequate and well controlled,
emphasizes
[[Page 84]]
an important aspect of adequacy. The Food and Drug Administration (FDA)
considers these characteristics in determining whether a study is
adequate and well controlled for purposes of section 512 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b). Adequate and
well-controlled studies, in addition to providing a basis for
determining whether a new animal drug is effective, may also be relied
upon to support target animal safety. The report of an adequate and
well-controlled study should provide sufficient details of study design,
conduct, and analysis to allow critical evaluation and a determination
of whether the characteristics of an adequate and well-controlled study
are present.
(b) Characteristics. An adequate and well-controlled study has the
following characteristics:
(1) The protocol for the study (protocol) and the report of the
study results (study report) must include a clear statement of the study
objective(s).
(2) The study is conducted in accordance with an appropriate
standard of conduct that addresses, among other issues, study conduct,
study personnel, study facilities, and study documentation. The protocol
contains a statement acknowledging the applicability of, and intention
to follow, a standard of conduct acceptable to FDA. The study report
contains a statement describing adherence to the standard.
(3) The study is conducted with a new animal drug that is produced
in accordance with appropriate manufacturing practices, which include,
but are not necessarily limited to, the manufacture, processing,
packaging, holding, and labeling of the new animal drug such that the
critical characteristics of identity, strength, quality, purity, and
physical form of the new animal drug are known, recorded, and
reproducible, to permit meaningful evaluations of and comparisons with
other studies conducted with the new animal drug. The physical form of a
new animal drug includes the formulation and physical characterization
(including delivery systems thereof, if any) of the new animal drug as
presented to the animal. The protocol and study report must include an
identification number which can be correlated with the specific
formulation and production process used to manufacture the new animal
drug used in the study.
(4) The study uses a design that permits a valid comparison with one
or more controls to provide a quantitative evaluation of drug effects.
The protocol and the study report must describe the precise nature of
the study design, e.g., duration of treatment periods, whether
treatments are parallel, sequential, or crossover, and the determination
of sample size. Within the broad range of studies conducted to support a
determination of the effectiveness of a new animal drug, certain of the
controls listed below would be appropriate and preferred depending on
the study conducted:
(i) Placebo concurrent control. The new animal drug is compared with
an inactive preparation designed to resemble the new animal drug as far
as possible.
(ii) Untreated concurrent control. The new animal drug is compared
with the absence of any treatment. The use of this control may be
appropriate when objective measurements of effectiveness, not subject to
observer bias, are available.
(iii) Active treatment concurrent control. The new animal drug is
compared with known effective therapy. The use of this control is
appropriate when the use of a placebo control or of an untreated
concurrent control would unreasonably compromise the welfare of the
animals. Similarity of the new animal drug and the active control drug
can mean either that both drugs were effective or that neither was
effective. The study report should assess the ability of the study to
have detected a difference between treatments. The evaluation of the
study should explain why the new animal drugs should be considered
effective in the study, for example, by reference to results in previous
placebo-controlled studies of the active control.
(iv) Historical control. The results of treatment with the new
animal drug are quantitatively compared with experience historically
derived from the adequately documented natural history of the disease or
condition, or with a
[[Page 85]]
regimen (therapeutic, diagnostic, prophylactic) whose effectiveness is
established, in comparable animals. Because historical control
populations usually cannot be as well assessed with respect to pertinent
variables as can concurrent control populations, historical control
designs are usually reserved for special circumstances. Examples include
studies in which the effect of the new animal drug is self-evident or
studies of diseases with high and predictable mortality, or signs and
symptoms of predictable duration or severity, or, in the case of
prophylaxis, predictable morbidity.
(5) The study uses a method of selecting animals that provides
adequate assurances that the animals are suitable for the purposes of
the study. For example, the animals can reasonably be expected to have
animal production characteristics typical of the class(es) of animals
for which the new animal drug is intended, there is adequate assurance
that the animals have the disease or condition being studied, or, in the
case of prophylactic agents, evidence of susceptibility and exposure to
the condition against which prophylaxis is desired has been provided.
The protocol and the study report describe the method of selecting
animals for the study.
(6) The study uses a method to assign a treatment or a control to
each experimental unit of animals that is random and minimizes bias.
Experimental units of animals are groups of animals that are comparable
with respect to pertinent variables such as age, sex, class of animal,
severity of disease, duration of disease, dietary regimen, level of
animal production, and use of drugs or therapy other than the new animal
drug. The protocol and the study report describe the method of
assignment of animals to an experimental unit to account for pertinent
variables and method of assignment of a treatment or a control to the
experimental units. When the effect of such variables is accounted for
by an appropriate design, and when, within the same animal, effects due
to the test drug can be obtained free of the effects of such variables,
the same animal may be used for both the test drug and the control using
the controls set forth in paragraph (b)(4) of this section.
(7) The study uses methods to minimize bias on the part of observers
and analysts of the data that are adequate to prevent undue influences
on the results and interpretation of the study data. The protocol and
study report explain the methods of observation and recording of the
animal response variables and document the methods, such as ``blinding''
or ``masking,'' used in the study for excluding or minimizing bias in
the observations.
(8) The study uses methods to assess animal response that are well
defined and reliable. The protocol and study report describe the methods
for conducting the study, including any appropriate analytical and
statistical methods, used to collect and analyze the data resulting from
the conduct of the study, describe the criteria used to assess response,
and, when appropriate, justify the selection of the methods to assess
animal response.
(9) There is an analysis and evaluation of the results of the study
in accord with the protocol adequate to assess the effects of the new
animal drug. The study report evaluates the methods used to conduct, and
presents and evaluates the results of, the study as to their adequacy to
assess the effects of the new animal drug. This evaluation of the
results of the study assesses, among other items, the comparability of
treatment and control groups with respect to pertinent variables and the
effects of any interim analyses performed.
(c) Field studies. (1) Field conditions as used in this section
refers to conditions which closely approximate the conditions under
which the new animal drug, if approved, is intended to be applied or
administered.
(2) Studies of a new animal drug conducted under field conditions
shall, consistent with generally recognized scientific principles and
procedures, use an appropriate control that permits comparison, employ
procedures to minimize bias, and have the characteristics generally
described in paragraph (b) of this section. However, because field
studies are conducted under field conditions, it is recognized that the
[[Page 86]]
level of control over some study conditions need not or should not be
the same as the level of control in laboratory studies. While not all
conditions relating to a field study need to be or should be controlled,
observations of the conditions under which the new animal drug is tested
shall be recorded in sufficient detail to permit evaluation of the
study. Adequate and well-controlled field studies shall balance the need
to control study conditions with the need to observe the true effect of
the new animal drug under closely approximated actual use conditions.
(d) Waiver. The Director of the Center for Veterinary Medicine (the
Director) may, on the Director's own initiative or on the petition of an
interested person, waive in whole or in part any of the criteria in
paragraph (b) of this section with respect to a specific study. A
petition for a waiver is required to set forth clearly and concisely the
specific criteria from which waiver is sought, why the criteria are not
reasonably applicable to the particular study, what alternative
procedures, if any, are to be, or have been employed, and what results
have been obtained. The petition is also required to state why the
studies so conducted will yield, or have yielded, substantial evidence
of effectiveness, notwithstanding nonconformance with the criteria for
which waiver is requested.
(e) Uncontrolled studies. Uncontrolled studies or partially
controlled studies are not acceptable as the sole basis for the approval
of claims of effectiveness or target animal safety. Such studies,
carefully conducted and documented, may provide corroborative support of
adequate and well-controlled studies regarding effectiveness and may
yield valuable data regarding safety of the new animal drug. Such
studies will be considered on their merits in light of the
characteristics listed here. Isolated case reports, random experience,
and reports lacking the details which permit scientific evaluation will
not be considered.
[63 FR 10770, Mar. 5, 1998]
Sec. 514.120 Revocation of order refusing to approve an application
or suspending or withdrawing approval of an application.
The Commissioner, upon his own initiative or upon request of an
applicant stating reasonable grounds therefor and if he finds that the
facts so require, may issue an order approving an application that
previously has had its approval refused, suspended, or withdrawn.
Sec. 514.121 Service of notices and orders.
All notices and orders under this subchapter E and section 512 of
the act pertaining to new animal drug applications shall be served:
(a) In person by any officer or employee of the Department
designated by the Commissioner; or
(b) By mailing the order by certified mail addressed to the
applicant or respondent at his last known address in the records of the
Food and Drug Administration.
Subpart C_Hearing Procedures
Sec. 514.200 Contents of notice of opportunity for a hearing.
(a) The notice to the applicant of opportunity for a hearing on a
proposal by the Commissioner to refuse to approve an application or to
withdraw the approval of an application will specify the grounds upon
which he proposes to issue his order. On request of the applicant, the
Commissioner will explain the reasons for his action. The notice of
opportunity for a hearing will be published in the Federal Register and
will specify that the applicant has 30 days after issuance of the notice
within which he is required to file a written appearance electing
whether:
(1) To avail himself of the opportunity for a hearing; or
(2) Not to avail himself of the opportunity for a hearing.
(b) If the applicant fails to file a written appearance in answer to
the notice of opportunity for hearing, his failure will be construed as
an election not to avail himself of the opportunity for the hearing, and
the Commissioner without further notice may enter a final order.
[[Page 87]]
(c) If the applicant elects to avail himself of the opportunity for
a hearing, he is required to file a written appearance requesting the
hearing within 30 days after the publication of the notice, giving the
reason why the application should not be refused or should not be
withdrawn, together with a well-organized and full-factual analysis of
the clinical and other investigational data he is prepared to prove in
support of his opposition to the Commissioner's proposal. A request for
a hearing may not rest upon mere allegations or denials, but must set
forth specific facts showing there is a genuine and substantial issue of
fact that requires a hearing. When it clearly appears from the data in
the application and from the reasons and a factual analysis in the
request for the hearing that no genuine and substantial issue of fact
precludes the refusal to approve the application or the withdrawal of
approval of the application (for example, no adequate and well-
controlled clinical investigations to support the claims of
effectiveness have been identified), the Commissioner will enter an
order on this data, stating his findings and conclusions. If a hearing
is requested and is justified by the applicant's response to the notice
of opportunity for a hearing, the issues will be defined, an
Administrative Law Judge will be named, and he shall issue a written
notice of the time and place at which the hearing will commence. In the
case of denial of approval, such time shall be not more than 90 days
after the expiration of such 30 days unless the Administrative Law Judge
and the applicant otherwise agree; and, in the case of withdrawal of
approval, such time shall be as soon as practicable.
(d) The hearing will be open to the public; however, if the
Commissioner finds that portions of the application which serve as a
basis for the hearing contain information concerning a method or process
entitled to protection as a trade secret, the part of the hearing
involving such portions will not be public, unless the respondent so
specifies in his appearance.
[40 FR 13825, Mar. 27, 1975, as amended at 43 FR 1941, Jan. 13, 1978]
Sec. 514.201 Procedures for hearings.
Hearings relating to new animal drugs under section 512(d) and (e)
of the act shall be governed by part 12 of this chapter.
[64 FR 63204, Nov. 19, 1999]
Subparts D-E [Reserved]
Subpart F_Judicial Review
Sec. 514.235 Judicial review.
(a) The transcript and record shall be certified by the
Commissioner. In any case in which the Commissioner enters an order
without a hearing pursuant to Sec. 314.200(g) of this chapter, the
request(s) for hearing together with the data and information submitted
and the Commissioner's findings and conclusions shall be included in the
record certified by the Commissioner.
(b) Judicial review of an order withdrawing approval of a new drug
application, whether or not a hearing has been held, may be sought by a
manufacturer or distributor of an identical, related, or similar drug
product, as defined in Sec. 310.6 of this chapter, in a United States
court of appeals pursuant to section 505(h) of the act.
[42 FR 4717, Jan. 25, 1977]
PART 515_MEDICATED FEED MILL LICENSE--Table of Contents
Subpart A_Applications
Sec.
515.10 Medicated feed mill license applications.
515.11 Supplemental medicated feed mill license applications.
Subpart B_Administrative Actions on Licenses
515.20 Approval of medicated feed mill license applications.
515.21 Refusal to approve a medicated feed mill license application.
515.22 Suspension and/or revocation of approval of a medicated feed mill
license.
515.23 Voluntary revocation of medicated feed mill license.
515.24 Notice of revocation of a medicated feed mill license.
[[Page 88]]
515.25 Revocation of order refusing to approve a medicated feed mill
license application or suspending or revoking a license.
515.26 Services of notices and orders.
Subpart C_Hearing Procedures
515.30 Contents of notice of opportunity for a hearing.
515.31 Procedures for hearings.
Subpart D_Judicial Review
515.40 Judicial review.
Authority: 21 U.S.C. 360b, 371.
Source: 64 FR 63204, Nov. 19, 1999 unless otherwise noted.
Subpart A_Applications
Sec. 515.10 Medicated feed mill license applications.
(a) Medicated feed mill license applications (Forms FDA 3448) may be
obtained from the Public Health Service, Consolidated Forms and
Publications Distribution Center, Washington Commerce Center, 3222
Hubbard Rd., Landover, MD 20785, or electronically from the Center for
Veterinary Medicine home page at http://www.fda.gov/cvm.
(b) A completed medicated feed mill license must contain the
following information:
(1) The full business name and address of the facility at which the
manufacturing is to take place.
(2) The facility's FDA registration number as required by section
510 of the Federal Food, Drug, and Cosmetic Act (the act).
(3) The name, title, and signature of the responsible individual or
individuals for that facility.
(4) A certification that the animal feeds bearing or containing new
animal drugs are manufactured and labeled in accordance with the
applicable regulations published under section 512(i) of the act.
(5) A certification that the methods used in, and the facilities and
controls used for, manufacturing, processing, packaging, and holding
such animal feeds conform to current good manufacturing practice as
described in section 501(a)(2)(B) of the act and in part 225 of this
chapter.
(6) A certification that the facility will establish and maintain
all records required by regulation or order issued under sections
512(m)(5)(A) or 504(a)(3)(A) of the act, and will permit access to, or
copying or verification of such records.
(7) A commitment that current approved Type B and/or Type C
medicated feed labeling for each Type B and/or Type C medicated feed to
be manufactured will be in the possession of the feed manufacturing
facility prior to receiving the Type A medicated article containing such
drug.
(8) A commitment to renew registration every year with FDA as
required in Sec. Sec. 207.20 and 207.21 of this chapter.
(c) Applications must be completed, signed, and submitted to the
Division of Animal Feeds (HFV-220), Center for Veterinary Medicine, Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
(d) Applications that are facially deficient will be returned to the
applicant. All reasons for the return of the application will be made
known to the applicant.
(e) Upon approval, the original copy of the application will be
signed by an authorized employee of FDA designated by the Commissioner
of Food and Drugs, and a copy will be returned to the applicant.
Sec. 515.11 Supplemental medicated feed mill license applications.
(a) After approval of a medicated feed mill license application to
manufacture animal feed, a supplemental application shall be submitted
for a change in ownership and/or a change in mailing address of the
facility site.
(b) Each supplemental application should be accompanied by a fully
completed Form FDA 3448 and include an explanation of the change.
(c) Within 30 working days after a supplemental application has been
filed, if the Commissioner of Food and Drugs determines that the
application provides adequate information respecting the change in
ownership and/or postal address of the facility site, then an authorized
employee of the Food and Drug Administration designated by the
Commissioner shall notify the applicant that it is approved by signing
and mailing to the applicant a copy of
[[Page 89]]
the Form FDA 3448. Supplemental applications that do not provide
adequate information shall be returned to the applicant and all reasons
for the return of the application shall be made known to the applicant.
Subpart B_Administrative Actions on Licenses
Sec. 515.20 Approval of medicated feed mill license applications.
Within 90 days after an application has been filed under Sec.
515.10, if the Commissioner of Food and Drugs (the Commissioner)
determines that none of the grounds for denying approval specified in
section 512(m)(3) of the Federal Food, Drug, and Cosmetic Act (the act)
applies, an authorized employee of the Food and Drug Administration
designated by the Commissioner shall notify the applicant that it is
approved by signing and mailing to the applicant a copy of the Form FDA
3448.
Sec. 515.21 Refusal to approve a medicated feed mill license application.
(a) The Commissioner of Food and Drugs (the Commissioner) shall
within 90 days, or such additional period as may be agreed upon by the
Commissioner and the applicant, after the filing of an application under
Sec. 515.10, inform the applicant in writing of his/her intention to
issue a notice of opportunity for a hearing on a proposal to refuse to
approve the application, if the Commissioner determines upon the basis
of the application, on the basis of a preapproval inspection, or upon
the basis of any other information before him that:
(1) The application is incomplete, false, or misleading in any
particular; or
(2) The methods used in and the facilities and controls used for the
manufacturing, processing, and packaging of such animal feed are not
adequate to preserve the identity, strength, quality, and purity of the
new animal drug therein; or
(3) The facility manufactures animal feeds bearing or containing new
animal drugs in a manner that does not accord with the specifications
for manufacture or labels animal feeds bearing or containing new animal
drugs in a manner that does not accord with the conditions or
indications of use that are published under section 512(i) of the act.
(b) The Commissioner, as provided in Sec. 515.30, shall
expeditiously notify the applicant of an opportunity for a hearing on
the question of whether such application is approvable, unless by the
30th day following the date of issuance of the letter informing the
applicant of the intention to issue a notice of opportunity for a
hearing the applicant:
(1) Withdraws the application; or
(2) Waives the opportunity for a hearing; or
(3) Agrees with the Commissioner on an additional period to preceed
issuance of such notice of hearing.
Sec. 515.22 Suspension and/or revocation of approval of a medicated
feed mill license.
(a) The Secretary of Health and Human Services may suspend a
medicated feed mill license approved under section 512(m)(2) of the
Federal Food, Drug, and Cosmetic Act (the act) and give the person
holding the medicated feed mill license application prompt notice of
this action and afford the applicant the opportunity for an expedited
hearing on a finding that there is an imminent hazard to the health of
man or of the animals for which such animal feed is intended.
(b) The Commissioner of Food and Drugs (the Commissioner) shall
notify in writing the person holding an application approved under
section 512(m)(2) of the act and afford an opportunity for a hearing on
a proposal to revoke approval of such application if the Commissioner
finds:
(1) That the application contains any untrue statement of a material
fact; or
(2) That the applicant has made any changes that would cause the
application to contain any untrue statements of material fact or that
would affect the safety or effectiveness of the animal feeds
manufactured at the facility unless the applicant has supplemented the
application by filing a supplemental application under Sec. 515.11.
(c) The Commissioner may notify in writing the person holding an
application approved under section 512(m)(2) of the act and afford an
opportunity for a
[[Page 90]]
hearing on a proposal to revoke approval of such application if the
Commissioner finds:
(1) That the applicant has failed to establish a system for
maintaining required records, or has repeatedly or deliberately failed
to maintain such records or to make required reports in accordance with
a regulation or order under sections 512(m)(5)(A) or 504(a)(3)(A) of the
act, or the applicant has refused to permit access to, or copying, or
verification of, such records as required by sections 512(m)(5)(B) or
504(a)(3)(B) of the act; or
(2) That on the basis of new information before him, evaluated
together with the evidence before him when such license was issued, the
methods used in, or the facilities and controls used for, the
manufacture, processing, packing, and holding of such animal feed are
inadequate to assure and preserve the identity, strength, quality, and
purity of the new animal drug therein, and were not made adequate within
a reasonable time after receipt of written notice from the Commissioner
specifying the matter complained of; or
(3) That on the basis of new information before him, evaluated
together with the evidence before him when such license was issued, the
labeling of any animal feeds, based on a fair evaluation of all material
facts, is false or misleading in any particular and was not corrected
within a reasonable time after receipt of written notice from the
Commissioner specifying the matter complained of; or
(4) That on the basis of new information before him, evaluated
together with the evidence before him when such license was issued, the
facility has manufactured, processed, packed, or held animal feed
bearing or containing a new animal drug adulterated under section
501(a)(6) of the act, and the facility did not discontinue the
manufacture, processing, packing, or holding of such animal feed within
a reasonable time after receipt of written notice from the Commissioner
specifying the matter complained of.
Sec. 515.23 Voluntary revocation of medicated feed mill license.
A license issued under section 512(m)(2) of the Federal Food, Drug,
and Cosmetic Act (the act) will be revoked on the basis of a request for
its revocation submitted in writing by a responsible individual holding
such license on the grounds that the facility no longer manufactures any
animal feed covered under Sec. 558.4(b) of this chapter. A written
request for such revocation shall be construed as a waiver of the
opportunity for a hearing as otherwise provided for in this section.
Revocation of approval of a medicated feed mill license under the
provisions of this paragraph shall be without prejudice.
Sec. 515.24 Notice of revocation of a medicated feed mill license.
When a license approved under section 512 of the Federal Food, Drug,
and Cosmetic Act (the act) is revoked by the Commissioner of Food and
Drugs (the Commissioner), the Commissioner will give appropriate public
notice of such action by publication in the Federal Register.
Sec. 515.25 Revocation of order refusing to approve a medicated feed
mill license application or suspending or revoking a license.
The Commissioner of Food and Drugs (the Commissioner), upon his/her
own initiative or upon request of an applicant stating reasonable
grounds therefor and if the Commissioner finds that the facts so
require, may issue an order approving a medicated feed mill license
application that previously has had its approval refused, suspended, or
revoked.
Sec. 515.26 Services of notices and orders.
All notices and orders under this part 515 and section 512 of the
Federal Food, Drug, and Cosmetic Act (the act) pertaining to medicated
feed mill licenses shall be served:
(a) In person by any officer or employee of the Department of Health
and Human Services designated by the Commissioner of Food and Drugs; or
[[Page 91]]
(b) By mailing the order by certified mail addressed to the
applicant or respondent at the applicant or respondent's last known
address in the records of the Food and Drug Administration.
Subpart C_Hearing Procedures
Sec. 515.30 Contents of notice of opportunity for a hearing.
(a) The notice to the applicant of opportunity for a hearing on a
proposal by the Commissioner of Food and Drugs (the Commissioner) to
refuse to approve a medicated feed mill license application or to revoke
the approval of a medicated feed mill license will specify the grounds
upon which the Commissioner proposes to issue this order. On request of
the applicant, the Commissioner will explain the reasons for the action.
The notice of opportunity for a hearing will be published in the Federal
Register and will specify that the applicant has 30 days after issuance
of the notice within which the Commissioner is required to file a
written appearance electing whether:
(1) To avail himself of the opportunity for a hearing; or
(2) Not to avail himself of the opportunity for a hearing.
(b) If the applicant fails to file a written appearance in answer to
the notice of opportunity for hearing, this failure will be construed as
an election not to avail himself of the opportunity for the hearing, and
the Commissioner without further notice may enter a final order.
(c) If the applicant elects to avail himself of the opportunity for
a hearing, the applicant is required to file a written appearance
requesting the hearing within 30 days after the publication of the
notice, giving the reason why the application should not be refused or
the medicated feed mill license should not be revoked, together with a
well-organized and full-factual analysis of the information the
applicant is prepared to prove in support of his opposition to the
Commissioner's proposal. A request for a hearing may not rest upon mere
allegations or denials, but must set forth specific facts showing there
is a genuine and substantial issue of fact that requires a hearing. When
it clearly appears from the information in the application and from the
reasons and factual analysis in the request for the hearing that no
genuine and substantial issue of fact precludes the refusal to approve
the application or the revocation of approval of the application, the
Commissioner will enter an order on this information, stating his/her
findings and conclusions. If a hearing is requested and is justified by
the applicant's response to the notice of opportunity for a hearing, the
issues will be defined, an Administrative Law Judge will be named, and
the Judge shall issue a written notice of the time and place at which
the hearing will commence. In the case of denial of approval, such time
shall be not more than 90 days after the expiration of such 30 days
unless the Administrative Law Judge and the applicant otherwise agree;
and, in the case of withdrawal of approval, such time shall be as soon
as practicable.
(d) The hearing will be open to the public; however, if the
Commissioner finds that portions of the application which serve as a
basis for the hearing contain information concerning a method or process
entitled to protection as a trade secret, the part of the hearing
involving such portions will not be public, unless the respondent so
specifies in the appearance.
Sec. 515.31 Procedures for hearings.
Hearings relating to new animal drugs under section 512(m)(3) and
(m)(4) of the Federal Food, Drug, and Cosmetic Act (the act) shall be
governed by part 12 of this chapter.
Subpart D_Judicial Review
Sec. 515.40 Judicial review.
The transcript and record shall be certified by the Commissioner of
Food and Drugs (the Commissioner). In any case in which the Commissioner
enters an order without a hearing under Sec. 314.200(g) of this
chapter, the request(s) for hearing together with the data and
information submitted and the Commissioner's findings and conclusions
shall be included in the record certified by the Commissioner.
[[Page 92]]
PART 520_ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
Sec.
520.23 Acepromazine maleate tablets.
520.44 Acetazolamide sodium soluble powder.
520.45 Albendazole oral dosage forms.
520.45a Albendazole suspension.
520.45b Albendazole paste.
520.48 Altrenogest solution.
520.62 Aminopentamide hydrogen sulphate tablets.
520.82 Aminopropazine fumarate oral dosage forms.
520.82a Aminopropazine fumarate tablets.
520.82b Aminopropazine fumarate, neomycin sulfate tablets.
520.88 Amoxicillin oral dosage forms.
520.88a Amoxicillin trihydrate film-coated tablets.
520.88b Amoxicillin trihydrate for oral suspension.
520.88c Amoxicillin trihydrate oral suspension.
520.88d Amoxicillin trihydrate soluble powder.
520.88e Amoxicillin trihydrate boluses.
520.88f Amoxicillin trihydrate tablets.
520.88g Amoxicillin trihydrate and clavulanate potassium film-coated
tablets.
520.88h Amoxicillin trihydrate and clavulanate potassium for oral
suspension.
520.90 Ampicillin oral dosage forms.
520.90a Ampicillin capsules.
520.90b Ampicillin trihydrate tablets.
520.90c Ampicillin trihydrate capsules.
520.90d Ampicillin trihydrate for oral suspension.
520.90e Ampicillin trihydrate soluble powder.
520.90f Ampicillin trihydrate boluses.
520.100 Amprolium oral dosage forms.
520.100a Amprolium drinking water.
520.100b Amprolium drench.
520.100c Amprolium crumbles.
520.110 Apramycin sulfate soluble powder.
520.154 Bacitracin oral dosage forms.
520.154a Soluble bacitracin methylene disalicylate.
520.154b Soluble bacitracin methylene disalicylate and streptomycin
sulfate oral powder.
520.154c Bacitracin zinc soluble powder.
520.182 Bicyclohexylammonium fumagillin.
520.222 Bunamidine hydrochloride.
520.246 Butorphanol tartrate tablets.
520.260 n-Butyl chloride capsules.
520.300 Cambendazole oral dosage forms.
520.300a Cambendazole suspension.
520.300b Cambendazole pellets.
520.300c Cambendazole paste.
520.309 Carprofen.
520.310 Caramiphen ethanedisulfonate and ammonium chloride tablets.
520.312 Carnidazole tablets.
520.314 Cefadroxil tablets.
520.315 Cefadroxil powder for oral suspension.
520.370 Cefpodoxime tablets.
520.390 Chloramphenicol oral dosage forms.
520.390a Chloramphenicol tablets.
520.390b Chloramphenicol capsules.
520.390c Chloramphenicol palmitate oral suspension.
520.420 Chlorothiazide tablets and boluses.
520.434 Chlorphenesin carbamate tablets.
520.445 Chlortetracycline oral dosage forms.
520.445a Chlortetracycline bisulfate/sulfamethazine bisulfate soluble
powder.
520.445b Chlortetracycline powder (chlortetracycline hydrochloride or
chlortetracycline bisulfate).
520.445c Chlortetracycline tablets and boluses.
520.446 Clindamycin capsules and tablets.
520.447 Clindamycin liquid.
520.452 Clenbuterol syrup.
520.455 Clomipramine hydrochloride tablets.
520.462 Clorsulon drench.
520.522 Cyclosporine.
520.530 Cythioate oral liquid.
520.531 Cythioate tablets.
520.534 Decoquinate.
520.538 Deracoxib.
520.540 Dexamethasone oral dosage forms.
520.540a Dexamethasone powder.
520.540b Dexamethasone tablets and boluses.
520.540c Dexamethasone chewable tablets.
520.550 Dextrose/glycine/electrolyte.
520.563 Diatrizoate meglumine and diatrizoate sodium oral solution.
520.580 Dichlorophene and toluene capsules.
520.581 Dichlorophene tablets.
520.600 Dichlorvos.
520.608 Dicloxacillin sodium monohydrate capsules.
520.620 Diethylcarbamazine oral dosage forms.
520.622 Diethylcarbamazine citrate oral dosage forms.
520.622a Diethylcarbamazine citrate tablets.
520.622b Diethylcarbamazine citrate syrup.
520.622c Diethylcarbamazine citrate chew- able tablets.
520.622d Diethylcarbamazine citrate capsules.
520.623 Diethylcarbamazine citrate, oxibendazole chewable tablets.
520.645 Difloxacin.
520.763 Dithiazanine iodide oral dosage forms.
520.763a Dithiazanine iodide tablets.
520.763b Dithiazanine iodide powder.
520.763c Dithiazanine iodide and piperazine citrate suspension.
520.784 Doxylamine succinate tablets.
520.804 Enalapril tablets.
[[Page 93]]
520.812 Enrofloxacin tablets.
520.813 Enrofloxacin oral solution.
520.816 Epsiprantel tablets.
520.823 Erythromycin phosphate.
520.863 Ethylisobutrazine hydrochloride tablets.
520.870 Etodolac.
520.903 Febantel oral dosage forms.
520.903a Febantel paste.
520.903b Febantel suspension.
520.903c [Reserved]
520.903d Febantel-praziquantel paste.
520.903e Febantel tablets.
520.905 Fenbendazole oral dosage forms.
520.905a Fenbendazole suspension.
520.905b Fenbendazole granules.
520.905c Fenbendazole paste.
520.905d Fenbendazole powder.
520.905e Fenbendazole blocks.
520.928 Firocoxib.
520.955 Florfenicol.
520.960 Flumethasone tablets.
520.970 Flunixin oral dosage forms.
520.970a Flunixin meglumine granules.
520.970b Flunixin meglumine paste.
520.1010 Furosemide.
520.1044 Gentamicin sulfate oral dosage forms.
520.1044a Gentamicin sulfate oral solution.
520.1044b Gentamicin sulfate pig pump oral solution.
520.1044c Gentamicin sulfate soluble powder.
520.1100 Griseofulvin.
520.1120 Haloxon oral dosage forms.
520.1120a Haloxon drench.
520.1120b Haloxon boluses.
520.1130 Hetacillin oral dosage forms.
520.1130a Hetacillin potassium capsules.
520.1130b Hetacillin potassium oral suspension.
520.1130c Hetacillin potassium tablets.
520.1157 Iodinated casein tablets.
520.1158 Iodochlorhydroxyquin boluses.
520.1182 Iron dextran oral suspension.
520.1192 Ivermectin paste.
520.1193 Ivermectin tablets and chewables.
520.1194 Ivermectin meal.
520.1195 Ivermectin liquid.
520.1196 Ivermectin and pyrantel pamoate chewable tablets.
520.1197 Ivermectin sustained-release bolus.
520.1198 Ivermectin and praziquantel paste.
520.1204 Kanamycin sulfate, aminopentamide hydrogen sulfate, pectin,
bismuth subcarbonate, activated attapulgite suspension.
520.1205 Kanamycin sulfate, pectin, bismuth subcarbonate, activated
attapulgite tablets.
520.1242 Levamisole hydrochloride oral dosage forms.
520.1242a Levamisole powder for oral solution.
520.1242b Levamisole hydrochloride tablet or oblet (bolus).
520.1242c Levamisole hydrochloride and piperazine dihydrochloride.
520.1242d Levamisole resinate.
520.1242e Levamisole hydrochloride effervescent tablets.
520.1242f Levamisole hydrochloride gel.
520.1242g Levamisole resinate and famphur paste.
520.1263 Lincomycin hydrochloride monohydrate oral dosage forms.
520.1263a Lincomycin hydrochloride monohydrate tablets and sirup.
520.1263b [Reserved]
520.1263c Lincomycin hydrochloride soluble powder.
520.1265 Lincomycin and spectinomycin soluble powder.
520.1284 Sodium liothyronine tablets.
520.1288 Lufenuron tablets.
520.1289 Lufenuron suspension.
520.1310 Marbofloxacin tablets.
520.1320 Mebendazole oral.
520.1326 Mebendazole and trichlorfon oral dosage forms.
520.1326a Mebendazole and trichlorfon powder.
520.1326b Mebendazole and trichlorfon paste.
520.1330 Meclofenamic acid granules.
520.1331 Meclofenamic acid tablets.
520.1341 Megestrol acetate tablets.
520.1350 Meloxicam.
520.1380 Methocarbamol tablets.
520.1390 (S)-methoprene.
520.1408 Methylprednisolone tablets.
520.1409 Methylprednisolone, aspirin tablets.
520.1422 Metoserpate hydrochloride.
520.1430 Mibolerone.
520.1445 Milbemycin oxime tablets.
520.1446 Milbemcyin oxime and lufenuron tablets.
520.1448 Monensin oral dosage forms.
520.1448a Monensin blocks.
520.1450 Morantel tartrate oral dosage forms.
520.1450a Morantel tartrate bolus.
520.1450b Morantel tartrate cartridge.
520.1450c Morantel tartrate sustained-release trilaminate cylinder/
sheet.
520.1451 Moxidectin.
520.1452 Moxidectin gel.
520.1453 Moxidectin and praziquantel gel.
520.1468 Naproxen granules.
520.1484 Neomycin sulfate soluble powder.
520.1485 Neomycin sulfate oral solution.
520.1498 Nitazoxanide paste.
520.1510 Nitenpyram tablets.
520.1615 Omeprazole.
520.1616 Orbifloxacin tablets.
520.1628 Oxfendazole powder and pellets.
520.1629 Oxfendazole paste.
520.1630 Oxfendazole suspension.
520.1631 Oxfendazole and trichlorfon paste.
520.1638 Oxibendazole paste.
520.1640 Oxibendazole suspension.
520.1660 Oxytetracycline.
[[Page 94]]
520.1660a Oxytetracycline and carbomycin in combination.
520.1660b Oxytetracycline hydrochloride capsules.
520.1660c Oxytetracycline hydrochloride tablets/boluses.
520.1660d Oxytetracycline hydrochloride soluble powder.
520.1696 Penicillin oral dosage forms.
520.1696a Buffered penicillin powder, penicillin powder with buffered
aqueous diluent.
520.1696b Penicillin G potassium in drinking water.
520.1696c Penicillin V potassium for oral solution.
520.1696d Penicillin V potassium tablets.
520.1720 Phenylbutazone oral dosage forms.
520.1720a Phenylbutazone tablets and boluses.
520.1720b Phenylbutazone granules.
520.1720c Phenylbutazone paste.
520.1720d Phenylbutazone gel.
520.1802 Piperazine-carbon disulfide complex oral dosage forms.
520.1802a Piperazine-carbon disulfide complex suspension.
520.1802b Piperazine-carbon disulfide complex boluses.
520.1802c Piperazine-carbon disulfide complex with phenothiazine
suspension.
520.1803 Piperazine citrate capsules.
520.1804 Piperazine phosphate capsules.
520.1805 Piperazine phosphate with thenium closylate tablets.
520.1806 Piperazine monohydrochloride liquid.
520.1807 Piperazine.
520.1840 Poloxalene.
520.1846 Polyoxyethylene (23) lauryl ether blocks.
520.1855 Ponazuril.
520.1870 Praziquantel tablets.
520.1871 Praziquantel/pyrantel pamoate tablets.
520.1872 Praziquantel, pyrantel pamoate, and febantel tablets.
520.1880 Prednisolone tablets.
520.1900 Primidone tablets.
520.1920 Prochlorperazine, isopropamide sustained release capsules.
520.1921 Prochlorperazine, isopropamide, with neomycin sustained-release
capsules.
520.1962 Promazine hydrochloride.
520.2002 Propiopromazine hydrochloride.
520.2041 Pyrantel pamoate chewable tablets.
520.2042 Pyrantel pamoate tablets.
520.2043 Pyrantel pamoate suspension.
520.2044 Pyrantel pamoate paste.
520.2045 Pyrantel tartrate powder; pyrantel tartrate pellets.
520.2087 Roxarsone soluble powder.
520.2088 Roxarsone tablets.
520.2089 Roxarsone liquid.
520.2098 Selegiline hydrochloride tablets.
520.2100 Selenium, vitamin E capsules.
520.2123 Spectinomycin dihydrochloride pentahydrate oral dosage forms.
520.2123a Spectinomycin dihydrochloride pentahydrate tablets.
520.2123b Spectinomycin dihydrochloride pentahydrate soluble powder.
520.2123c Spectinomycin dihydrochloride pentahydrate solution.
520.2150 Stanozolol oral dosage forms.
520.2150a Stanozolol tablets.
520.2150b Stanozolol chewable tablets.
520.2158 Streptomycin/dihydrostreptomycin oral dosage forms.
520.2158a Streptomycin sulfate oral solution.
520.2158b Dihydrostreptomycin tablets.
520.2158c Dihydrostreptomycin oral suspension.
520.2160 Styrylpyridinium, diethylcarbamazine oral dosage forms.
520.2170 Sulfabromomethazine sodium boluses.
520.2184 Sodium sulfachloropyrazine monohydrate.
520.2200 Sulfachlorpyridazine oral dosage forms.
520.2200a Sulfachlorpyridazine bolus.
520.2200b Sulfachlorpyridazine medicated milk and drinking water.
520.2200c Sulfachlorpyridazine tablets.
520.2215 Sulfadiazine/pyrimethamine suspension.
520.2220 Sulfadimethoxine oral dosage forms.
520.2220a Sulfadimethoxine oral solution and soluble powder.
520.2220b Sulfadimethoxine tablets and boluses.
520.2220c Sulfadimethoxine oral suspension.
520.2220d Sulfadimethoxine-ormetoprim tablets.
520.2240 Sulfaethoxypyridazine.
520.2240a Sulfaethoxypyridazine drinking water.
520.2240b Sulfaethoxypyridazine tablets.
520.2260 Sulfamethazine oral dosage forms.
520.2260a Sulfamethazine oblet, tablet, and bolus.
520.2260b Sulfamethazine sustained-release boluses.
520.2260c Sulfamethazine sustained-release tablets.
520.2261 Sulfamethazine sodium oral dosage forms.
520.2261a Sulfamethazine sodium drinking water solution.
520.2261b Sulfamethazine sodium soluble powder.
520.2280 Sulfamethizole and methenamine mandelate tablets.
520.2320 Sulfanitran and aklomide in combination.
520.2325 Sulfaquinoxaline oral dosage forms.
520.2325a Sulfaquinoxaline drinking water.
520.2325b Sulfaquinoxaline drench.
520.2330 Sulfisoxazole tablets.
520.2340 Tepoxalin.
[[Page 95]]
520.2345 Tetracycline oral dosage forms.
520.2345a Tetracycline hydrochloride capsules.
520.2345b Tetracycline tablets.
520.2345c Tetracycline boluses.
520.2345d Tetracycline hydrochloride soluble powder.
520.2345e Tetracycline oral liquid.
520.2345f Tetracycline phosphate complex and sodium novobiocin capsules.
520.2345g Tetracycline hydrochloride and sodium novobiocin tablets.
520.2345h Tetracycline hydrochloride, sodium novobiocin, and
prednisolone tablets.
520.2362 Thenium closylate tablets.
520.2380 Thiabendazole oral dosage forms.
520.2380a Thiabendazole top dressing and mineral protein feed block.
520.2380b Thiabendazole drench or oral paste.
520.2380c Thiabendazole bolus.
520.2380d Thiabendazole, piperazine citrate suspension.
520.2380e Thiabendazole with trichlorfon.
520.2380f Thiabendazole, piperazine phosphate powder.
520.2455 Tiamulin soluble powder.
520.2456 Tiamulin liquid concentrate.
520.2473 Tioxidazole oral dosage forms.
520.2473a Tioxidazole granules.
520.2473b Tioxidazole paste.
520.2481 Triamcinolone acetonide tablets.
520.2482 Triamcinolone acetonide oral powder.
520.2520 Trichlorfon oral dosage forms.
520.2520b Trichlorfon and atropine.
520.2520e Trichlorofon boluses.
520.2520f Trichlorofon granules.
520.2520g Trichlorfon, phenothiazine, and piperazine dihydrochloride
powder.
520.2582 Triflupromazine hydrochloride tablets.
520.2604 Trimeprazine tartrate and prednisolone tablets.
520.2605 Trimeprazine tartrate and prednisolone capsules.
520.2610 Trimethoprim and sulfadiazine tablets.
520.2611 Trimethoprim and sulfadiazine oral paste.
520.2612 Trimethoprim and sulfadiazine oral suspension.
520.2613 Trimethoprim and sulfadiazine powder.
520.2640 Tylosin.
Authority: 21 U.S.C. 360b.
Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
Sec. 520.23 Acepromazine maleate tablets.
(a) Sponsors. See drug labeler codes in Sec. 510.600(c) of this
chapter for identification of sponsors as follows:
(1) For No. 000856, use of 5-, 10-, or 25-milligram tablets as in
paragraph (b) of this section.
(2) For No. 000010, use of 10- or 25-milligram tablets as in
paragraph (c) of this section.
(b) Conditions of use. It is used in dogs and cats as follows:
(1) Indications for use. It is used in dogs and cats as a
tranquilizer.
(2) Amount. Dogs: 0.25 to 1.0 milligram per pound of body weight;
Cats: 0.5 to 1.0 milligram per pound of body weight.
(3) Limitations. The drug is administered orally. Dosage may be
repeated as required. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(c) Conditions of use. It is used in dogs as follows:
(1) Indications for use. It is used in dogs as an aid in
tranquilization and as a preanesthetic agent.
(2) Amount. Dogs: 0.25 to 1.0 milligram per pound of body weight.
(3) Limitations. The drug is administered orally. Dosage may be
repeated as required. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
[46 FR 44443, Sept. 4, 1981, as amended at 49 FR 49091, Dec. 18, 1984;
52 FR 666, Jan. 8, 1987; 53 FR 40727, Oct. 18, 1988; 56 FR 37473, Aug.
7, 1991; 62 FR 35075, June 30, 1997]
Sec. 520.44 Acetazolamide sodium soluble powder.
(a) Specifications. The drug is in a powder form containing
acetazolamide sodium, USP equivalent to 25 percent acetazolamide
activity.
(b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used in dogs as an aid in the
treatment of mild congestive heart failure and for rapid reduction of
intraocular pressure.\1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(2) It is administered orally at a dosage level of 5 to 15
milligrams per pound of body weight daily.\1\
[[Page 96]]
(3) For use only by or on the order of a licensed veterinarian.\1\
[40 FR 13838, Mar. 27, 1975, as amended at 67 FR 78355, Dec. 24, 2002]
Sec. 520.45 Albendazole oral dosage forms.
Sec. 520.45a Albendazole suspension.
(a)(1) Specifications. The product contains 11.36 percent
albendazole.
(2) Sponsor. See No. 000069 in Sec. 510.600 of this chapter.
(3) Related tolerances. See Sec. 556.34 of this chapter.
(4) Conditions of use in cattle--(i) Amount. 4.54 milligrams per
pound of body weight (10 milligrams per kilogram).
(ii) Indications for use. For removal and control of the following
internal parasites of cattle: Adult liver flukes (Fasciola hepatica);
heads and segments of tapeworms (Moniezia benedeni, M. expansa); adult
and 4th stage larvae of stomach worms (brown stomach worms including 4th
stage inhibited larvae (Ostertagia ostertagi), barberpole worm
(Haemonchus contortus, H. placei), small stomach worm (Trichostrongylus
axei)); adult and 4th stage larvae of intestinal worms (thread-necked
intestinal worm (Nematodirus spathiger, N. helvetianus), small
intestinal worm (Cooperia punctata and C. oncophora)); adult stages of
intestinal worms (hookworm (Bunostomum phlebotomum), bankrupt worm
(Trichostrongylus colubriformis), nodular worm (Oesophagostomum
radiatum)); adult and 4th stage larvae of lungworms (Dictyocaulus
viviparus).
(iii) Limitations. Administer as a single oral dose using dosing gun
or dosing syringe. Do not slaughter within 27 days of last treatment. Do
not use in female dairy cattle of breeding age: Do not administer to
female cattle during first 45 days of pregnancy or for 45 days after
removal of bulls. Consult your veterinarian for assistance in the
diagnosis, treatment, and control of parasitism.
(b)(1) Specifications. The product contains 4.55 or 11.36 percent
albendazole.
(2) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(3) Related tolerances. See Sec. 556.34 of this chapter.
(4) Conditions of use in sheep--(i) Amount. 7.5 milligrams per
kilogram of body weight (3.4 milligrams per pound).
(ii) Indications for use. For removal and control of the following
internal parasites of sheep: Adult liver flukes (Fasciola hepatica,
Fascioloides magna); heads and segments of common tapeworms (Moniezia
expansa) and fringed tapeworm (Thysanosoma actinioides); adult and
fourth stage larvae of stomach worms (brown stomach worm (Ostertagia
circumcinta and Marshallagia marshalli), barberpole worm (Haemonchus
contortus), small stomach worm (Trichostrongylus axei)); adult and
fourth stage larvae of intestinal worms (thread-necked intestinal worm
(Nematodirus spathiger and N. filicollis), Cooper's worm (Cooperia
oncophora), bankrupt worm (Trichostrongylus colubriformis), nodular worm
(Oesophagostomum columbianum), and large-mouth bowel worm (Chabertia
ovina)); adult and larval stages of lungworms (Dictyocaulus filaria).
(iii) Limitations. Administer as a single oral dose using dosing gun
or dosing syringe. Do not slaughter within 7 days of last treatment. Do
not administer to ewes during first 30 days of pregnancy or for 30 days
after removal of rams. Consult your veterinarian for assistance in the
diagnosis, treatment, and control of parasitism.
[54 FR 25115, June 13, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 59
FR 65711, Dec. 21, 1994; 60 FR 55658, Nov. 2, 1995; 61 FR 4875, Feb. 9,
1996; 64 FR 1504, Jan. 11, 1999]
Sec. 520.45b Albendazole paste.
(a) Specifications. The product contains 30 percent albendazole.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.34 of this chapter.
(d) Conditions of use in cattle--(1) Amount. Equivalent to 4.54
milligrams per 1 pound of body weight (10 milligrams per kilogram).
(2) Indications for use. For removal and control of the following
internal parasites of cattle: adult liver flukes (Fasciola hepatica);
heads and segments of tapeworms (Moniezia benedeni, M. expansa); adult
and 4th stage larvae of stomach worms (brown stomach worms including 4th
stage inhibited larvae
[[Page 97]]
(Ostertagia ostertagi); barberpole worm (Haemonchus contortus, H.
placei); small stomach worm (Trichostrongylus axei)); adult and 4th
stages larvae of intestinal worms (thread-necked intestinal worm
(Nematodirus spathiger, N. helvetianus); small intestinal worm (Cooperia
punctata and C. oncophora)); adult stages of intestinal worms (hookworm
(Bunostomum phlebotmum); bankrupt worm (Trichostrongylus colubriformis),
nodular worm (Oesophagostomum radiatum)); adult and 4th stage larvae of
lungworms (Dictyocaulus viviparus).
(3) Limitations. Administer as a single oral dose. Do not slaughter
within 27 days of last treatment. Do not use in female dairy cattle of
breeding age. Do not administer to female cattle during first 45 days of
pregnancy or for 45 days after removal of bulls. Consult your
veterinarian for assistance in the diagnosis, treatment, and control of
parasitism.
[54 FR 51385, Dec. 15, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60
FR 55658, Nov. 2, 1995]
Sec. 520.48 Altrenogest solution.
(a) Specifications. Each milliliter (mL) of solution contains 2.2
milligrams (mg) altrenogest.
(b) Sponsor. See No. 057926 in Sec. 510.600(c) of this chapter.
(c) Tolerances. See Sec. 556.36 of this chapter.
(d) Conditions of use--(1)Horses--(i)Amount. 1.0 mL per 110 pounds
body weight (0.044 mg/kg) daily for 15 consecutive days.
(ii) Indications for use. For suppression of estrus in mares.
(iii) Limitations. For oral use in horses only; avoid contact with
the skin. Do not administer to horses intended for use as food. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) Swine--(i) Amount. Administer 6.8 mL (15 mg altrenogest) per
gilt once daily for 14 consecutive days by top-dressing on a portion of
each gilt's daily feed.
(ii) Indications for use. For synchronization of estrus in sexually
mature gilts that have had at least one estrous cycle.
(iii) Limitations. Do not use in gilts having a previous or current
history of uterine inflammation (i.e., acute, subacute or chronic
endometritis). Gilts must not be slaughtered for human consumption for
21 days after the last treatment.
[66 FR 47960, Sept. 17, 2001, as amended at 68 FR 62006, Oct. 31, 2003]
Sec. 520.62 Aminopentamide hydrogen sulphate tablets.
(a) Chemical name. 4-(Dimethylamino)-2,2-diphenylvaleramide hydrogen
sulfate.
(b) Specifications. Each tablet contains 0.2 milligram of the drug.
(c) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) It is intended for use in dogs and cats
only for the treatment of vomiting and/or diarrhea, nausea, acute
abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.
Note: Not for use in animals with glaucoma because of the occurrence
of mydriasis.
(2) Dosage is administered by oral tablet every 8 to 12 hours, as
follows:
------------------------------------------------------------------------
Dosage in
Weight of animal in pounds milligrams
------------------------------------------------------------------------
Up to 10.................................................... 0.1
11 to 20.................................................... 0.2
21 to 50.................................................... 0.3
51 to 100................................................... 0.4
Over 100.................................................... 0.5
------------------------------------------------------------------------
Dosage may be gradually increased up to a maximum of five times the
suggested dosage. Oral administration of tablets may be preceded by
subcutaneous or intramuscular use of the injectable form of the drug.
(3) For use only by or on the order of a licensed veterinarian.
[40 FR 13838, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988]
Sec. 520.82 Aminopropazine fumarate oral dosage forms.
Sec. 520.82a Aminopropazine fumarate tablets.
(a) Specifications. The drug is in tablet form. Each tablet contains
aminopropazine fumarate equivalent to 25 milligrams of aminopropazine
base.
[[Page 98]]
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is used in dogs and cats for
reducing excessive smooth muscle contractions, such as occur in urethral
spasms associated with urolithiasis.\1\
(2) It is administered at a dosage level of 1 to 2 milligrams per
pound of body weight. The dosage can be repeated every 12 hours, as
indicated.\1\
(3) Not for use in animals intended for food purposes.
(4) For use only by or on the order of a licensed veterinarian.\1\
[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61
FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]
Sec. 520.82b Aminopropazine fumarate, neomycin sulfate tablets.
(a) Specifications. The drug is in tablet form. Each tablet contains
both aminopropazine fumarate equivalent to 25 milligrams of
aminopropazine base and neomycin sulfate equivalent to 50 milligrams of
neomycin base.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is used in dogs to control
bacterial diarrhea caused by organisms susceptible to neomycin and to
reduce smooth muscle contractions.\1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(2) It is administered at a dosage level of one to two tablets per
10 pounds of body weight twice daily for 3 days.\1\
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.\1\
[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61
FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]
Sec. 520.88 Amoxicillin oral dosage forms.
Sec. 520.88a Amoxicillin trihydrate film-coated tablets.
(a) Specifications. Each tablet contains amoxicillin trihydrate
equivalent to 50, 100, 150, 200, or 400 milligrams of amoxicillin.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. 5 milligrams per pound
of body weight, twice a day.
(ii) Indications for use. Treatment of infections of the respiratory
tract (tonsillitis, tracheobronchitis), genitourinary tract (cystitis),
gastrointestinal tract (bacterial gastroenteritis), and soft tissues
(abscesses, lacerations, wounds), caused by susceptible strains of
Staphylococcus aureus, Streptococcus spp., Escherichia coli, Proteus
mirabilis, and bacterial dermatitis caused by S. aureus, Streptococcus
spp., and P. mirabilis.
(iii) Limitations. Administer for 5 to 7 days or 48 hours after all
symptoms have subsided. If no improvement is seen in 5 days, review
diagnosis and change therapy. Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
(2) Cats--(i) Amount. 50 milligrams (5 to 10 milligrams per pound of
body weight) once a day.
(ii) Indications for use. Treatment of infections caused by
susceptible organisms as follows: upper respiratory tract due to S.
aureus, Streptococcus spp., and E. coli; genitourinary tract (cystitis)
due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis;
gastrointestinal tract due to E. coli; and skin and soft tissue
(abscesses, lacerations, and wounds) due to S. aureus, Streptococcus
spp., E. coli, and Pasteurella multocida.
(iii) Limitations. Administer for 5 to 7 days or 48 hours after all
symptoms have subsided. If no improvement is seen in 5 days, review
diagnosis and change therapy. Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
[57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995]
Sec. 520.88b Amoxicillin trihydrate for oral suspension.
(a) Specifications. When reconstituted, each milliliter contains
amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
[[Page 99]]
(1) Conditions of use--(i) Dogs--(A) Amount. 5 milligrams per pound
of body weight twice daily.
(B) Indications for use. Treatment of infections caused by
susceptible strains of organisms as follows: respiratory tract
(tonsillitis, tracheobronchitis) caused by Staphylococcus aureus,
Streptococcus spp., Escherichia coli, and Proteus mirabilis;
genitourinary tract (cystitis) caused by S. aureus, Streptococcus spp.,
E. coli, and P. mirabilis; gastrointestinal tract (bacterial
gastroenteritis) caused by S. aureus, Streptococcus spp., E. coli, and
P. mirabilis; bacterial dermatitis caused by S. aureus, Streptococcus
spp., and P. mirabilis; and soft tissues (abscesses, lacerations, and
wounds) caused by S. aureus, Streptococcus spp., E. coli, and P.
mirabilis.
(C) Limitations. Use for 5 to 7 days or 48 hours after all symptoms
have subsided. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
(ii) Cats--(A) Amount. 50 milligrams (5 to 10 milligrams per pound)
once daily.
(B) Indications for use. Treatment of infections caused by
susceptible strains of organisms as follows: upper respiratory tract due
to Staphylococcus spp., Streptococcus spp., Hemophilus spp., E. coli,
Pasteurella spp., and P. mirabilis; genitourinary tract (cystitis) due
to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and
Corynebacterium spp.; gastrointestinal tract due to E. coli, Proteus
spp., Staphylococcus spp., and Streptococcus spp.; skin and soft tissue
(abscesses, lacerations, and wounds) due to Staphylococcus spp.,
Streptococcus spp., E. coli, and Pasteurella multocida.
(C) Limitations. Use for 5 to 7 days or 48 hours after all symptoms
have subsided. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
(2) [Reserved]
(c) Sponsors. See Nos. 000856 and 051311 in Sec. 510.600(c) of this
chapter.
(1) Conditions of use. Dogs--(i) Amount. 5 milligrams per pound of
body weight twice daily.
(ii) Indications for use. Treatment of bacterial dermatitis due to
S. aureus, Streptococcus spp., Staphylococcus spp., and E. coli, and
soft tissue infections (abscesses, wounds, lacerations) due to S.
aureus, Streptococcus spp., E. coli, P. mirabilis and Staphylococcus
spp.
(iii) Limitations. Use for 5 to 7 days. Continue for 48 hours after
all symptoms have subsided. If no improvement is seen in 5 days, review
diagnosis and change therapy. Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
(2) [Reserved]
[57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at
60 FR 55658, Nov. 2, 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, Nov.
6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, Sept. 29, 2003]
Sec. 520.88c Amoxicillin trihydrate oral suspension.
(a) Specifications. Each 0.8-milliliter dose contains amoxicillin
trihydrate equivalent to 40 milligrams of amoxicillin.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.510 of this chapter.
(d) Conditions of use. Swine--(1) Amount. 40 milligrams orally,
twice a day using a dosing pump.
(2) Indications for use. Treatment of baby pigs under 10 pounds for
porcine colibacillosis caused by Escherichia coli susceptible to
amoxicillin.
(3) Limitations. Treat animals for 48 hours after all symptoms have
subsided but not beyond 5 days. Do not slaughter during treatment or for
15 days after latest treatment. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
[57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995]
Sec. 520.88d Amoxicillin trihydrate soluble powder.
(a) Specifications. Each gram contains amoxicillin trihydrate
equivalent to 115.4 milligrams of amoxicillin.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.38 of this chapter.
(d) Conditions of use. Preruminating calves including veal calves--
(1) Amount. 400 milligrams per 100 pounds of body weight twice daily.
[[Page 100]]
(2) Indications for use. Treatment of bacterial enteritis when due
to susceptible Escherichia coli in preruminating calves including veal
calves.
(3) Limitations. Administer by drench or by mixing in milk.
Treatment should be continued for 48 hours after all symptoms have
subsided but not to exceed 5 days. For use in preruminating calves
including veal calves only, not for use in other animals which are
raised for food production. Do not slaughter animals during treatment or
for 20 days after the latest treatment. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
[57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304,
Apr. 8, 1993, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb.
6, 1997]
Sec. 520.88e Amoxicillin trihydrate boluses.
(a) Specifications. Each bolus contains the equivalent of 400
milligrams of amoxicillin.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.38 of this chapter.
(d) Conditions of use. Preruminating calves including veal calves--
(1) Amount. 400 milligrams per 100 pounds of body weight twice daily.
(2) Indications for use. Treatment of bacterial enteritis when due
to susceptible Escherichia coli in preruminating calves including veal
calves.
(3) Limitations. For oral use in preruminating calves including veal
calves only, not for use in other animals which are raised for food
production. Treatment should be continued for 48 hours after all
symptoms have subsided but not to exceed 5 days. Do not slaughter
animals during treatment or for 20 days after the latest treatment.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 62
FR 5526, Feb. 6, 1997]
Sec. 520.88f Amoxicillin trihydrate tablets.
(a) Specifications. Each tablet contains amoxicillin trihydrate
equivalent to 50, 100, 200, or 400 milligrams of amoxicillin.
(b) Sponsors. See Nos. 000856 and 051311 in Sec. 510.600(c) of this
chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. 5 milligrams per pound
of body weight twice a day.
(ii) Indications for use. Treatment of bacterial dermatitis due to
Staphylococcus aureus, Streptococcus spp., Staphylococcus spp., and
Escherichia coli; and soft tissue infections (abscesses, wounds,
lacerations) due to S. aureus, Streptococcus spp., E. coli, Proteus
mirabilis, and Staphylococcus spp.
(iii) Limitations. Use for 5 to 7 days or 48 hours after all
symptoms have subsided. If no improvement is seen in 5 days, review
diagnosis and change therapy. Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
(2) [Reserved]
[57 FR 37320, Aug. 18, 1992, as amended at 62 FR 13302, Mar. 20, 1997;
67 FR 67521, Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824,
Sept. 29, 2003]
Sec. 520.88g Amoxicillin trihydrate and clavulanate potassium film-coated
tablets.
(a) Specifications. Each tablet contains amoxicillin trihydrate and
clavulanate potassium, equivalent to either 50 milligrams of amoxicillin
and 12.5 milligrams clavulanic acid, or 100 milligrams of amoxicillin
and 25 milligrams clavulanic acid, or 200 milligrams amoxicillin and 50
milligrams clavulanic acid or 300 milligrams amoxicillin and 75
milligrams clavulanic acid.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. 6.25 milligrams
(equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic
acid) per pound of body weight twice daily.
(ii) Indications for use. Treatment of skin and soft tissue
infections such as wounds, abscesses, cellulitis, superficial/juvenile
and deep pyoderma due to susceptible strains of beta-lactamase
(penicillinase) Staphylococcus aureus, nonbeta-lactamase S. aureus,
Staphylococcus spp., Streptococcus spp., and Escherichia coli. Treatment
of periodontal infections due to
[[Page 101]]
susceptible strains of aerobic and anaerobic bacteria.
(iii) Limitations. Wounds, abscesses, cellulitis, and superficial/
juvenile pyoderma: Treat for 5 to 7 days or for 48 hours after all signs
have subsided. If no improvement is seen after 5 days of treatment,
discontinue therapy and reevaluate diagnosis. Deep pyoderma may require
treatment for 21 days; do not treat for more than 30 days. Not for use
in dogs maintained for breeding. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(2) Cats--(i) Amount. 62.5 milligrams (1 milliliter) (50 milligrams
amoxicillin and 12.5 milligrams clavulanic acid) twice daily.
(ii) Indications for use. Treatment of skin and soft tissue
infections, such as wounds, abscesses and cellulitis/dermatitis due to
susceptible strains of beta-lactamase (penicillinase) producing S.
aureus, nonbeta-lactamase producing S. aureus, Staphylococcus spp.,
Streptococcus spp., E. coli, and Pasteurella spp. Also, treatment of
urinary tract infections (cystitis) due to susceptible strains of E.
coli.
(iii) Limitations. Skin and soft tissue infections: abscesses,
cellulitis/dermatitis should be treated for 5 to 7 days or for 48 hours
after all signs have subsided. If no response is seen after 3 days of
treatment, therapy should be discontinued and diagnosis reevaluated.
Urinary tract infections may require treatment for 10 to 14 days or
longer. The maximum duration of treatment should not exceed 30 days.
Safety of use in pregnant or breeding animals has not been established.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63
FR 13121, Mar. 18, 1998]
Sec. 520.88h Amoxicillin trihydrate and clavulanate potassium for oral
suspension.
(a) Specifications. When reconstituted, each milliliter contains
amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin with
clavulanate potassium equivalent to 12.5 milligrams of clavulanic acid.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. 6.25 milligrams
(equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic
acid) per pound of body weight twice daily.
(ii) Indications for use. Treatment of skin and soft tissue
infections such as wounds, abscesses, cellulitis, superficial/juvenile
and deep pyoderma due to susceptible strains of beta-lactamase
(penicillinase) producing Staphylococcus aureus, nonbeta-lactamase
Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and
Escherichia coli. Treatment of periodontal infections due to susceptible
strains of aerobic and anaerobic bacteria.
(iii) Limitations. Administer for 5 to 7 days or 48 hours after all
symptoms subsided. Deep pyoderma may require 21 days, not to exceed 30
days. If no improvement is seen in 5 days, discontinue therapy and
reevaluate the case. Not for use in dogs maintained for breeding.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) Cats--(i) Amount. 62.5 milligrams (1 milliliter) (50 milligrams
of amoxicillin and 12.5 milligrams clavulanic acid) twice daily.
(ii) Indications for use. Treatment of feline skin and soft tissue
infections, such as wounds, abscesses and cellulitis/dermatitis due to
susceptible strains of beta-lactamase (penicillinase) producing S.
aureus, nonbeta-lactamase S. aureus, Staphylococcus spp., Streptococcus
spp., E. coli, Pasteurella multocida, and Pasteurella spp.
(iii) Limitations. Administer 48 hours after all symptoms have
subsided. If no improvement is seen after 3 days of treatment,
discontinue therapy and reevaluate diagnosis. Maximum duration of
treatment should not exceed 30 days. Not for use in cats maintained for
breeding. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63
FR 13121, Mar. 18, 1998]
[[Page 102]]
Sec. 520.90 Ampicillin oral dosage forms.
Sec. 520.90a Ampicillin capsules.
(a) Specifications. Each capsule contains 125 milligrams or 250
milligrams of ampicillin.
(b) Sponsor. See No. 000008 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. 5 to 10 milligrams per
pound of body weight, e.g., one 125 mg capsule per 14 to 25 pounds,
given 2 to 4 times daily; for animals weighing 6 to 14 pounds, one
capsule twice daily.
(ii) Indications for use. Treatment of urinary tract infections
(cystitis) due to Proteus spp., hemolytic and nonhemolytic streptococci,
beta hemolytic streptococci, and Escherichia coli. In upper respiratory
tract infections tracheobronchitis (kennel cough), tonsillitis due to
alpha and beta hemolytic streptococci, hemolytic positive staphylococci,
E. coli, and Proteus spp. In infections associated with abscesses,
lacerations, and wounds due to Staphylococcus spp. and Streptococcus
spp.
(iii) Limitations. Bacteriologic studies to determine the causative
organisms and their susceptibility to ampicillin should be performed.
Use of the drug is contraindicated in animals with a history of an
allergic reaction to any of the penicillins. Ampicillin is
contraindicated in infections caused by penicillinase-producing
organisms. Not for use in animals which are raised for food production.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) Cats--(i) Amount. 125 milligrams twice daily; in more acute
conditions three times daily.
(ii) Indications for use. Treatment of respiratory tract infections
(bacterial pneumonia) due to alpha and beta hemolytic streptococci,
hemolytic positive staphylococci, E. coli, and Proteus spp. In
infections associated with abscesses, lacerations, and wounds due to
Staphylococcus spp. and Streptococcus spp.
(iii) Limitations. Bacteriologic studies to determine the causative
organisms and their susceptibility to ampicillin should be performed.
Use of the drug is contraindicated in animals with a history of an
allergic reaction to any of the penicillins. Ampicillin is
contraindicated in infections caused by penicillinase-producing
organisms. Not for use in animals which are raised for food production.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
[57 FR 37321, Aug. 18, 1992]
Sec. 520.90b Ampicillin trihydrate tablets.
(a) Specifications. Each tablet contains ampicillin trihydrate
equivalent to 50 or 100 milligrams of ampicillin.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. Dogs--(1) Amount. 5 milligrams per pound of
body weight, at 8-hour intervals, 1 to 2 hours prior to feeding, to be
continued 36 to 48 hours after all symptoms have subsided. If no
improvement is seen within 5 days, stop treatment, reevaluate diagnosis,
and change therapy.
(2) Indications for use. Oral treatment of infections caused by
susceptible organisms as follows: Upper respiratory infections,
tonsillitis, and bronchitis due to Streptococcus spp., Staphylococcus
spp., Escherichia coli, Proteus mirabilis, and Pasteurella spp., urinary
tract infections (cystitis) due to Streptococcus spp., Staphylococcus
spp., E., coli, P. mirabilis, and Enterococcus spp.; gastrointestinal
infections due to Staphylococcus spp., Streptococcus spp., Enterococcus
spp., and E. coli. ; infections associated with abscesses, lacerations,
and wounds caused by Staphylococcus spp., and Streptococcus spp.
(3) Limitations. Not for use in animals which have shown
hypersensitivity to penicillin or for infections caused by
penicillinase-producing organisms. Not for use in animals which are
raised for food production. Federal law restricts this drug to use by or
on the order of a licensed veterinarian.
[57 FR 37321, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995]
Sec. 520.90c Ampicillin trihydrate capsules.
(a) Specifications. Each capsule contains ampicillin trihydrate
equivalent to 125, 250, or 500 milligrams of ampicillin.
(b) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter.
[[Page 103]]
(c) Conditions of use--(1) Dogs--(i) Amount. 5 to 10 milligrams per
pound of body weight two or three times daily. In severe or acute
conditions, 10 milligrams per pound of body weight, three times daily.
Administer 1 to 2 hours prior to feeding.
(ii) Indications for use. Treatment against strains of gram-negative
and gram-positive organisms sensitive to ampicillin and associated with
respiratory tract infections (tracheobronchitis and tonsillitis);
urinary tract infections (cystitis); bacterial gastroenteritis;
generalized infections (septicemia) associated with abscesses,
lacerations, and wounds; and bacterial dermatitis.
(iii) Limitations. The drug may be given as an emergency measure;
however, in vitro sensitivity tests on samples collected prior to
treatment should be made. Ampicillin is contraindicated for use in
infections caused by penicillinase-producing organisms and for use in
animals known to be allergic to any of the penicillins. Not for use in
animals raised for food production. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
(2) Cats--(i) Amount. 10 to 30 milligrams per pound of body weight
or three times daily. Administer 1 to 2 hours prior to feeding.
(ii) Indications for use. Treatment against strains of gram-negative
and gram-positive organisms sensitive to ampicillin and associated with
respiratory tract infections (bacterial pneumonia); urinary tract
infections (cystitis); and generalized infections (septicemia)
associated with abscesses, lacerations, and wounds.
(iii) Limitations. The drug may be given as an emergency measure;
however, in vitro sensitivity tests on samples collected prior to
treatment should be made. Ampicillin is contraindicated for use in
infections caused by penicillinase-producing organisms and for use in
animals known to be allergic to any of the penicillins. Not for use in
animals raised for food production. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
[57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993]
Sec. 520.90d Ampicillin trihydrate for oral suspension.
(a) Specifications. When reconstituted as directed, each milliliter
contains ampicillin trihydrate equivalent to 25 milligrams of
ampicillin.
(b) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. 5 to 10 milligrams per
pound of body weight orally, 2 or 3 times daily, 1 to 2 hours prior to
feeding. In severe or acute conditions, 10 milligrams per pound of body
weight 3 times daily.
(ii) Indications for use. Treatment of respiratory tract infections
(tracheobronchitis and tonsillitis) due to Escherichia coli, Pseudomonas
spp., Proteus spp., Staphylococcus spp., and Streptococcus spp., urinary
tract infections (cystitis) due to E. coli, Staphylococcus spp.,
Streptococcus spp., and Proteus spp.; bacterial gastroenteritis due to
E. coli; generalized infections (septicemia) associated with abscesses,
lacerations, and wounds, due to Staphylococcus spp. and Streptococcus
spp.; bacterial dermatitis due to Staphylococcus spp., Streptococcus
spp., Proteus spp., and Pseudomonas spp.
(iii) Limitations. Duration of treatment is usually 3 to 5 days.
Continue treatment 48 hours after the animal's temperature has returned
to normal and all other signs of infection have subsided. If no response
is obtained within 3 to 5 days, reevaluate diagnosis and treatment.
Appropriate laboratory tests should be conducted, including in vitro
culturing and susceptibility tests on samples collected prior to
treatment. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
(2) Cats--(i) Amount. 10 to 30 milligrams per pound of body weight
orally, 2 or 3 times daily, 1 to 2 hours prior to feeding.
(ii) Indications for use. Treatment of respiratory tract infections
(bacterial pneumonia) due to Staphylococcus spp., Streptococcus spp., E.
coli, and Proteus spp.; urinary tract infections (cystitis) due to E.
coli, Staphylococcus spp., Streptococcus spp., Proteus spp., and
Corynebacterium spp.; generalized infections (septicemia) associated
with abscesses, lacerations, and wounds, due
[[Page 104]]
to Staphylococcus spp., Streptococcus spp., Bacillus spp., and
Pasteurella spp.
(iii) Limitations. Duration of treatment is usually 3 to 5 days.
Continue treatment 48 hours after the animal's temperature has returned
to normal and all other signs of infection have subsided. If no response
is obtained within 3 to 5 days, reevaluate diagnosis and treatment.
Appropriate laboratory tests should be conducted, including in vitro
culturing and susceptibility tests on samples collected prior to
treatment. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
[57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993]
Sec. 520.90e Ampicillin trihydrate soluble powder.
(a) Specifications. Each gram contains ampicillin trihydrate
equivalent to 88.2 milligrams of ampicillin.
(b) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.40 of this chapter.
(d) Conditions of use. Swine--(1) Amount. 5 milligrams of ampicillin
per pound of body weight twice daily, orally by gavage or in drinking
water for up to 5 days.
(2) Indications for use. Oral treatment of porcine colibacillosis
(Escherichia coli) and salmonellosis (Salmonella spp.) infections in
swine up to 75 pounds of body weight, and bacterial pneumonia caused by
Pasteurella multocida, Staphylococcus spp., Streptococcus spp., and
Salmonella spp.
(3) Limitations. For use in swine only. Not for use in other animals
which are raised for food production. Treated swine must not be
slaughtered for food during treatment and for 24 hours following the
last treatment. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
[57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993]
Sec. 520.90f Ampicillin trihydrate boluses.
(a) Specifications. Each bolus contains ampicillin trihydrate
equivalent to 400 milligrams of ampicillin.
(b) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter for
use as in paragraph (d)(1), 000069 for use as in paragraph (d)(2).
(c) Related tolerances. See Sec. 556.40 of this chapter.
(d) Conditions of use. Nonruminating calves--(1) Amount. 5
milligrams per pound of body weight twice daily for up to 5 days.
(i) Indications for use. Oral treatment of colibacillosis caused by
Escherichia coli, bacterial enteritis caused by Salmonella spp., and
bacterial pneumonia caused by Pasteurella spp.
(ii) Limitations. Treated calves must not be slaughtered for food
during treatment and for 15 days after the last treatment. Not for use
in other animals raised for food production. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
(2) Amount. 5 milligrams per pound of body weight twice daily not to
exceed 4 days.
(i) Indications for use. Oral treatment of bacterial enteritis
(colibacillosis) caused by E. coli.
(ii) Limitations. Treated calves must not be slaughtered for food
during treatment and for 7 days after the last treatment. Not for use in
other animals raised for food production. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
[57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993;
60 FR 55659, Nov. 2, 1995]
Sec. 520.100 Amprolium oral dosage forms.
Sec. 520.100a Amprolium drinking water.
(a) Chemical name. 1-(4-Amino-2-n-propyl-5-pyrimidinylmethyl)-2-
picolinium chloride hydrochloride.
(b) Sponsor. See No. 050604 in Sec. 510.600 (c) of this chapter.
(c) Related tolerances. See Sec. 556.50 of this chapter.
(d) Conditions of use. It is used in drinking water as follows:
(1) Chickens and turkeys--(i) Amount. 20 percent soluble powder.
(ii) Indications for use. Treatment of coccidiosis.
(iii) Limitations. Administer at the 0.012 percent level in drinking
water as soon as coccidiosis is diagnosed and continue for from 3 to 5
days (in severe outbreaks, give amprolium at the 0.024
[[Page 105]]
percent level); continue with 0.006 percent amprolium-medicated water
for an additional 1 to 2 weeks; no other source of drinking water should
be available to the birds during this time; as sole source of amprolium.
(2) Calves--(i) Amount. 9.6 percent solution or 20 percent soluble
powder.
(a) Indications for use. As an aid in the treatment of coccidiosis
caused by Eimeria bovis and E. zurnii.
(b) Limitations. Add 16 fluid ounces of the 9.6 percent solution to
each 100 gallons of drinking water; or 4 ounces of the soluble powder to
each 50 gallons of drinking water; at the usual rate of water
consumption, this will provide an intake of approximately 10 milligrams
per kilogram (2.2 pounds) of body weight; offer this solution as the
only source of water for 5 days; for a satisfactory diagnosis, a
microscopic examination of the feces should be done by a veterinarian or
diagnostic laboratory before treatment; when treating outbreaks, the
drug should be administered promptly after diagnosis is determined;
withdraw 24 hours before slaughter.
(ii) Amount. 9.6 percent solution or 20 percent soluble powder.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by Eimeria bovis and E. zurnii.
(b) Limitations. Add 8 fluid ounces of the 9.6 percent solution or 4
ounces of the 20 percent soluble powder to each 100 gallons of drinking
water; at the usual rate of water consumption, this will provide an
intake of approximately 5 milligrams per kilogram (2.2 pounds) of body
weight; offer this solution as the only source of water for 21 days
during periods of exposure or when experience indicates that coccidiosis
is likely to be a hazard; withdraw 24 hours before slaughter.
[40 FR 13838, Mar. 27, 1975, as amended at 62 FR 63270, Nov. 28, 1997]
Sec. 520.100b Amprolium drench.
(a) Chemical name. 1-(4-Amino-2-n-propyl - 5 - pyrimidinylmethyl) -
2 - picolinium chloride hydrochloride.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.50 of this chapter.
(d) Conditions of use. It is used for calves as follows:
(1) Amount. 9.6 percent solution or 20 percent soluble powder.
(i) Indications for use. As an aid in the treatment of coccidiosis
caused by Eimeria bovis and E. zurnii.
(ii) Limitations. Add 3 fluid ounces of the 9.6 percent solution to
1 pint of water or 3 ounces of the 20 percent soluble powder to each
quart of water and with a dose syringe administer 1 fluid ounce of this
solution for each 100 pounds of body weight; this will provide a dose of
approximately 10 milligrams per kilogram (2.2 pounds) of body weight;
administer daily for 5 days; for a satisfactory diagnosis, a microscopic
examination of the feces should be done by a veterinarian or diagnostic
laboratory before treatment; when treating outbreaks, the drug should be
administered promptly after diagnosis is determined; withdraw 24 hours
before slaughter.
(2) Amount. 9.6 percent solution or 20 percent soluble powder.
(i) Indications for use. As an aid in the prevention of coccidiosis
caused by Eimeria bovis and E. zurnii.
(ii) Limitations. Add 1\1/2\ fluid ounces of the 9.6 percent
solution to 1 pint of water or 1\1/2\ ounces of the 20 percent soluble
powder to each quart of water and with a dose syringe administer 1 fluid
ounce of this solution for each 100 pounds of body weight; this will
provide a dose of approximately 5 milligrams per kilogram (2.2 pounds)
of body weight; administer daily for 21 days during periods of exposure
or when experience indicates that coccidiosis is likely to be a hazard;
withdraw 24 hours before slaughter.
[40 FR 13838, Mar. 27, 1975, as amended at 62 FR 63270, Nov. 28, 1997]
Sec. 520.100c Amprolium crumbles.
(a) Specifications. Amprolium crumbles contain 1.25 percent
amprolium.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.50 of this chapter.
(d) Conditions of use. It is top-dressed on or thoroughly mixed in
the daily feed ration of calves as follows:
(1) Amount. 1.6 ounces of crumbles per 250 pounds of body weight per
day (5
[[Page 106]]
milligrams per kilogram of body weight).
(i) Indications for use. As an aid in the prevention of coccidiosis
caused by Eimeria bovis and E. zurnii.
(ii) Limitations. Administer for 21 consecutive days during periods
of exposure or when experience indicates that coccidiosis is likely to
be a hazard. Withdraw 24 hours before slaughter. Use as sole source of
amprolium.
(2) Amount. 3.2 ounces of crumbles per 250 pounds of body weight per
day (10 milligrams per kilogram of body weight).
(i) Indications for use. As an aid in the treatment of coccidiosis
caused by Eimeria bovis and E. zurnii.
(ii) Limitations. Administer for 5 consecutive days. For
satisfactory diagnosis, a microscopic fecal examination should be done
by a veterinarian or diagnostic laboratory before treatment. When
treating outbreaks, the drug should be administered promptly after
diagnosis is determined. Withdraw 24 hours before slaughter. Use as sole
source of amprolium.
[42 FR 41855, Aug. 19, 1977, as amended at 62 FR 63270, Nov. 28, 1997]
Sec. 520.110 Apramycin sulfate soluble powder.
(a) Specifications. A water soluble powder used to make a medicated
drinking water containing apramycin sulfate equivalent to 0.375 gram of
apramycin activity per gallon of drinking water.
(b) Sponsor. See No. 000986 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.52 of this chapter.
(d) Conditions of use. (1) In swine for control of porcine
colibacillosis (weanling pig scours) caused by strains of E. coli
sensitive to apramycin.
(2) It is administered for 7 days in drinking water at the rate of
12.5 milligrams of apramycin per kilogram (5.7 milligrams per pound) of
body weight per day. Swine will normally consume 1 gallon per day of
medicated water containing 375 milligrams of apramycin for each 66
pounds of body weight. Water consumption should be monitored to
determine that the required amount of apramycin is being consumed. The
drug concentration should be adjusted according to water consumption
which varies depending on ambient temperature, humidity, and other
factors.
(3) Prepare fresh medicated water daily.
(4) Do not slaughter treated swine for 28 days following treatment
[47 FR 15771, Apr. 13, 1982, as amended at 49 FR 19642, May 9, 1984; 53
FR 37753, Sept. 28, 1988]
Sec. 520.154 Bacitracin oral dosage forms.
Sec. 520.154a Soluble bacitracin methylene disalicylate.
(a) Specifications. Each pound of soluble powder contains the
equivalent of 50 grams of bacitracin activity for use as in paragraph
(d)(1) or (d)(2) of this section, or the equivalent of 200 grams of
bacitracin activity for use as in paragraph (d) of this section.
(b) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.70 of this chapter.
(d) Conditions of use--(1) Growing turkeys--(i) Amount. 400
milligrams per gallon in drinking water.
(ii) Indications for use. Aid in the control of transmissible
enteritis complicated by organisms susceptible to bacitracin methylene
disalicylate.
(iii) Limitations. Prepare a fresh solution daily.
(2) Broiler and replacement chickens--(i) Amount. 100 milligrams per
gallon in drinking water.
(A) Indications for use. Aid in the prevention of necrotic enteritis
caused by Clostridium perfringens susceptible to bacitracin methylene
disalicylate.
(B) Limitations. Prepare a fresh solution daily.
(ii) Amount. 200 to 400 milligrams per gallon in drinking water.
(A) Indications for use. Aid in the control of necrotic enteritis
caused by C. perfringens susceptible to bacitracin methylene
disalicylate.
(B) Limitations. Prepare a fresh solution daily.
(3) Swine--(i) Amount. 1 gram per gallon in drinking water.
(ii) Indications for use. Treatment of swine dysentery associated
with Treponema hyodysenteriae. Administer
[[Page 107]]
continuously for 7 days or until signs of dysentery disappear.
(iii) Limitations. Prepare a fresh solution daily. Treatment not to
exceed 14 days. If symptoms persist after 4 to 5 days consult a
veterinarian. Not to be given to swine that weigh more than 250 pounds.
(4) Growing quail--(i) Amount. 400 milligrams per gallon in drinking
water.
(ii) Indications for use. For prevention of ulcerative enteritis due
to Clostridium colinum susceptible to bacitracin methylene disalicylate.
(iii) Limitations. Prepare fresh solution daily. Use as sole source
of drinking water.
[57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at
63 FR 38474, July 17, 1998; 64 FR 13068, Mar. 17, 1999]
Sec. 520.154b Soluble bacitracin methylene disalicylate and streptomycin
sulfate oral powder.
(a) Specifications. Each gram contains 200 units of soluble
bacitracin methylene disalicylate, streptomycin sulfate equivalent to 20
milligrams of streptomycin, and 850 milligrams of carob flour.
(b) Sponsor. See No. 062925 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. Dogs--(1) Amount. 1 level teaspoonful per 10
pounds of body weight three times daily, mixed in a small quantity of
liquid or feed.
(2) Indications for use. Treatment of bacterial enteritis caused by
pathogens susceptible to bacitracin and streptomycin such as Escherichia
coli, Proteus spp., Staphylococcus spp., and Streptococcus spp., and for
the symptomatic treatment of associated diarrhea.
(3) Limitations. If no improvement is noted in 2 to 3 days,
diagnosis should be reevaluated. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
[57 FR 37322, Aug. 18, 1992, as amended at 61 FR 66581, Dec. 18, 1996]
Sec. 520.154c Bacitracin zinc soluble powder.
(a) Specifications. Each pound contains the equivalent of not less
than 5 grams of bacitracin.
(b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.70 of this chapter.
(d) Conditions of use. (1) Broiler chickens--(i) Amount. 100
milligrams per gallon in drinking water.
(A) Indications for use. Prevention of necrotic enteritis caused by
Clostridium perfringens susceptible to bacitracin zinc.
(B) Limitations. Prepare a fresh solution daily.
(ii) Amount. 200 to 400 milligrams per gallon in drinking water.
(A) Indications for use. Control of necrotic enteritis caused by
Clostridium perfringens susceptible to bacitracin zinc.
(B) Limitations. Prepare a fresh solution daily.
(2) Growing quail--(i) Amount. 500 milligrams per gallon in drinking
water for 5 days followed by 165 milligrams per gallon in drinking water
for 10 days.
(ii) Indications for use. Control of ulcerative enteritis caused by
Clostridium spp. susceptible to bacitracin zinc.
(iii) Limitations. Prepare a fresh solution daily.
[57 FR 37322, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002]
Sec. 520.182 Bicyclohexylammonium fumagillin.
(a) Specifications. The drug is a sol- uble powder containing
bicyclohexylammonium fumagillin and appropriate phosphate buffers.
(b) Sponsor. See No. 059620 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is used for the prevention of
nosema in honey bees.\1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(2) It is administered usually in a 2:1 sugar sirup containing a
concentration of from 75 to 100 milligrams of fumagillin activity per
gallon of sugar sirup.\1\
(3) Colonies used for package production should be fed medicated
sirup as a principal food supply for a month prior
[[Page 108]]
to stocking nuclei or shaking packages for market.\1\
(4) The medicated sirup should not be fed immediately before or
during the honey flow.
[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 65151, Dec. 30, 1977;
56 FR 43699, Sept. 4, 1991; 58 FR 5608, Jan. 22, 1993]
Sec. 520.222 Bunamidine hydrochloride.
(a) Chemical name. N,N-Dibutyl-4-(hexyloxy)-1-naphthamidine
hydrochloride.
(b) Specifications. The drug is an oral tablet containing 100, 200,
or 400 milligrams of bunamidine hydrochloride.
(c) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) The drug is intended for oral
administration to dogs for the treatment of the tapeworms Dipylidium
caninum, Taenia pisiformis, and Echinococcus granulosus, and to cats for
the treatment of the tapeworms Dipylidium caninum and Taenia
taeniaeformis.
(2) It is administered to cats and dogs at the rate of 25 to 50
milligrams per kilogram of body weight. The drug should be given on an
empty stomach and food should not be given for 3 hours following
treatment.
(3) Tablets should not be crushed, mixed with food, or dissolved in
liquid. Repeat treatments should not be given within 14 days. The drug
should not be given to male dogs within 28 days prior to their use for
breeding. Do not administer to dogs or cats having known heart
conditions.
(4) For use only by or on the order of a licensed veterinarian.
[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 13018, Mar. 8, 1977; 46
FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19,
1997]
Sec. 520.246 Butorphanol tartrate tablets.
(a) Specifications. Each tablet contains 1, 5, or 10 milligrams of
butorphanol base activity as butorphanol tartrate.
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. The drug is used for the treatment of dogs as
follows:
(1) Amount. 0.25 milligram of butorphanol base activity per pound of
body weight.
(2) Indications for use. For the relief of chronic nonproductive
cough associated with tracheo-bronchitis, tracheitis, tonsillitis,
laryngitis, and pharyngitis associated with inflammatory conditions of
the upper respiratory tract.
(3) Limitations. For oral use in dogs only. Repeat at intervals of 6
to 12 hours as required. If necessary, increase dose to a maximum of 0.5
milligram per pound of body weight. Treatment should not normally be
required for longer than 7 days. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
[47 FR l4702, Apr. 6, 1982, as amended at 53 FR 27851, July 25, 1988]
Sec. 520.260 n-Butyl chloride capsules.
(a)(1) Specifications. n-Butyl chloride capsules, veterinary contain
272 milligrams or 816 milligrams of n-butyl chloride in each capsule.
(2) Sponsor. See No. 021091 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) It is used for the removal of ascarids
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma
caninum, Ancylostoma braziliense, and Uncinaria stenocephala) from dogs
and of the ascarid (Toxocara cati) and hookworm (Ancylostoma tubaeforme)
from cats.
(ii)(a) Animals should not be fed for 18 to 24 hours before being
given the drug. Puppies and kittens should be wormed at 6 weeks of age.
However, if heavily infested, they may be wormed at 4 or 5 weeks of age.
Administration of the drug should be followed in \1/2\ to 1 hour with a
teaspoonful to a tablespoonful of milk of magnesia or 1 or 2 milk of
magnesia tablets. Normal rations may be resumed 4 to 8 hours after
treatment. Puppies and kittens should be given a repeat treatment in a
week or 10 days. After that they should be treated every 2 months (or as
symptoms reappear) until a year old. When the puppy or kitten is a year
old, one treatment every 3 to 6 months is sufficient.
(b) For dogs or cats that have been wormed regularly, treatment
every 3 to 6 months will be sufficient. If a dog or cat has not been
wormed previously and has the symptoms of large roundworms a dose should
be given and
[[Page 109]]
repeated in 10 days. Removal of hookworms may require 3 or 4 doses at
10-day intervals.
(c) Puppies, dogs, cats, or kittens weighing 1 to 3 pounds should be
given 2 capsules per dose which contain 272 milligrams of n-butyl
chloride each. Such animals weighing 4 to 5 pounds should be given 3
such capsules. Animals weighing 6 to 7 pounds should be given 4 such
capsules and animals weighing 8 to 9 pounds should be given 5 such
capsules. Animals weighing 10 to 20 pounds should be given 3 capsules
which contain 816 milligrams of n-butyl chloride each, animals weighing
20 to 40 pounds should be given 4 such capsules and animals weighing
over 40 pounds should be given 5 such capsules with the maximum dosage
being 5 capsules, each of which contains 816 milligrams of n-butyl
chloride.
(iii) A veterinarian should be consulted before using in severely
debilitated dogs or cats and also prior to repeated use in cases which
present signs of persistent parasitism.
(b)(1) Specifications. n-Butyl chloride capsules contain 221, 442,
884, or 1,768 milligrams or 4.42 grams of n-butyl chloride in each
capsule. \1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter.
---------------------------------------------------------------------------
(2) Sponsors. See No. 023851 in Sec. 510.600(c) of this chapter for
221, 442, 884, or 1,768 milligram or 4.42 gram capsules; No. 000115 or
038782 for 884 or 1,768 milligram or 4.42 gram capsules; and No. 000069
for 221 milligram capsules.
(3) Conditions of use. (i) It is used for the removal of ascarids
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma
caninum, Ancylostoma braziliense, and Uncinaria stenocephala) from dogs.
\1\
(ii)(a) Dogs should not be fed for 18 to 24 hours before being given
the drug. Administration of the drug should be followed in \1/2\ to 1
hour with a mild cathartic. Normal feeding may be resumed 4 to 8 hours
after treatment. Animals subject to reinfection may be retreated in 2
weeks. \1\
(b) The drug is administered orally to dogs. Capsules containing 221
milligrams of n-butyl chloride are administered to dogs weighing under 5
pounds at a dosage level of 1 capsule per 1\1/4\ pound of body weight.
Capsules containing 442 milligrams of n-butyl chloride are administered
to dogs weighing under 5 pounds at a dosage level of 1 capsule per 2\1/
2\ pounds body weight. Capsules containing 884 milligrams of n-butyl
chloride are administered to dogs as follows: Weighing under 5 pounds, 1
capsule; weighing 5 to 10 pounds, 2 capsules; weighing 10 to 20 pounds,
3 capsules; weighing 20 to 40 pounds, 4 capsules; over 40 pounds, 5
capsules. Capsules containing 1,768 milligrams of n-butyl chloride are
administered at a dosage level of 1 capsule per dog weighing 5 to 10
pounds. Capsules containing 4.42 grams of n-butyl chloride are
administered at a dosage level of 1 capsule per dog weighing 40 pounds
or over. \1\
(iii) A veterinarian should be consulted before using in severely
debilitated dogs. \1\
(c)(1) Specifications. n-Butyl chloride capsules, veterinary contain
884 or 1,768 milligrams or 4.42 grams of n-butyl chloride in each
capsule.
(2) Sponsor. See No. 000115 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) It is used for the removal of ascarids
(Toxocara canis and Toxascaris leonina) and hookworms (Ancyclostoma
caninum, Ancyclostoma braziliense, and Uncinaria stenocephala) from
dogs.
(ii)(a) Dogs should not be fed for 18 to 24 hours before being given
the drug. Administration of the drug should be followed in \1/2\ to 1
hour with a mild cathartic. Normal rations may be resumed 4 to 8 hours
after treatment.
(b) The drug is administered orally to dogs. Capsules containing 884
milligrams of n-butyl chloride are administered to dogs as follows:
weighing under 5 pounds, 1 capsule; weighing 5-10 pounds, 2 capsules;
weighing 10-20 pounds, 3 capsules; weighing 20-40 pounds, 4 capsules;
over 40 pounds, 5 capsules. Capsules containing 1,768 milligrams of n-
butyl chloride are administered at a dosage level of 1 capsule per dogs
to dogs weighing 5-10 pounds and 2 capsules per dog to dogs weighing 20-
40 pounds. Capsules containing 4.42
[[Page 110]]
grams of n-butyl chloride are administered at dosage level of 1 capsule
per dog to dogs weighing 40 pounds or over.
(iii) A veterinarian should be consulted before using in severely
debilitated dogs.
[40 FR 13838, Mar. 27, 1975, as amended at 40 FR 39858, Aug. 29, 1975;
44 FR 10059, Feb. 16, 1979; 54 FR 38515, Sept. 19, 1989; 55 FR 24556,
June 18, 1990; 64 FR 15684, Apr. 1, 1999]
Sec. 520.300 Cambendazole oral dosage forms.
Sec. 520.300a Cambendazole suspension.
(a) Specifications. Each fluid ounce contains 0.9 gram of
cambendazole.
(b) Sponsor. No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used in horses for the control of
large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small
strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum,
Oesophagodontus); roundworms (Parascaris); pinworms. (Oxyuris); and
threadworms (Strongyloides).
(2) It is administered by stomach tube or as a drench at a dose of
0.9 gram of cambendazole per 100 pounds of body weight (20 milligrams
per kilogram).
(3) For animals maintained on premises where reinfection is likely
to occur, re-treatments may be necessary. For most effective results,
re-treat in 6 to 8 weeks.
(4) Not for use in horses intended for food.
(5) Caution: Do not administer to pregnant mares during first 3
months of pregnancy.
(6) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 13838, Mar. 27, 1975. Redesignated at 41 FR 1276, Jan. 7, 1976,
and amended at 42 FR 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997]
Sec. 520.300b Cambendazole pellets.
(a) Specifications. The drug is in feed pellets containing 5.3
percent cambendazole.
(b) Sponsor. No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used in horses for the control of
large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small
strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum,
Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and
threadworms (Strongyloides).
(2) Administer 20 milligrams cambendazole per kilogram body weight
(6 ounces per 1,000 pounds) by mixing with normal grain ration given at
one feeding. Doses for individual horses should be mixed and fed
separately to assure that each horse will consume the correct amount.
(3) For animals maintained on premises where reinfection is likely
to occur, re-treatments may be necessary. For most effective results,
re-treat in 6 to 8 weeks.
(4) Not for use in horses intended for food.
(5) Caution: Do not administer to pregnant mares during first 3
months of pregnancy.
(6) Consult your veterinarian for assistance in the diagnosis,
treatment, and control of parasitism.
[41 FR 1276, Jan. 7, 1976, as amended at 42 FR 3838, Jan. 21, 1977; 62
FR 63270, Nov. 28, 1997]
Sec. 520.300c Cambendazole paste.
(a) Specifications. The drug is a paste containing 45 percent
cambendazole.
(b) Sponsor. No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is used in horses for the control of
large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small
strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum,
Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and
threadworms (Strongyloides).
(2) Administer 20 milligrams cambendazole per kilogram body weight
(5 grams per 550 pounds (250 kilograms)) by depositing the paste on the
back of the tongue using a dosing gun.
(3) For animals maintained on premises where reinfection is likely
to occur, re-treatments may be necessary. For most effective results,
re-treat in 6 to 8 weeks.
(4) Not for use in horses intended for food.
[[Page 111]]
(5) Caution: Do not administer to pregnant mares during first 3
months of pregnancy.
(6) Consult your veterinarian for assistance in the diagnosis,
treatment, and control of parasitism.
[41 FR 1276, Jan. 7, 1976, as amended at 42 FR 3838, Jan. 21, 1977; 62
FR 63270, Nov. 28, 1997]
Sec. 520.309 Carprofen.
(a) Specifications. (1) Each caplet contains 25, 75, or 100
milligrams (mg) carprofen.
(2) Each chewable tablet contains 25, 75, or 100 mg carprofen.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use in dogs--(1) Amount. 2 mg per pound (/lb) of
body weight once daily or 1 mg/lb twice daily. For the control of
postoperative pain, administer approximately 2 hours before the
procedure.
(2) Indications for use. For the relief of pain and inflammation
associated with osteoarthritis, and for the control of postoperative
pain associated with soft tissue and orthopedic surgery.
(3) Limitations. Federal Law restricts this drug to use by or on the
order of a licensed veterinarian.
[61 FR 66581, Dec. 18, 1996, as amended at 64 FR 32181, June 16, 1999;
66 FR 63165, Dec. 5, 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, Oct.
23, 2002; 67 FR 65697, Oct. 28, 2002]
Sec. 520.310 Caramiphen ethanedisulfonate and ammonium chloride tablets.
(a) Specifications. Each tablet contains 10 milligrams of
5stcaramiphen ethanedisulfonate and 80 milligrams of ammonium
chloride.\1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. One tablet per 15 to 30
pounds of body weight every 4 to 6 hours.\1\
(2) Indications for use. For relief of cough.\1\
[43 FR 55385, Nov. 28, 1978]
Sec. 520.312 Carnidazole tablets.
(a) Specifications. Each tablet contains 10 milligrams of
carnidazole.
(b) Sponsor. See 053923 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Adult pigeons: 1 tablet (10
milligrams); newly weaned pigeons: \1/2\ tablet (5 milligrams).
(2) Indications for use. For treating trichomoniasis (canker) in
ornamental and homing pigeons.
(3) Limitations. Not for use in pigeons intended for human food.
Consult your veterinarian for assistance in the diagnosis, treatment,
and control of parasitism or when severely ill birds do not respond to
treatment.
[54 FR 32336, Aug. 7, 1989]
Sec. 520.314 Cefadroxil tablets.
(a) Specifications. 50-, 100-, and 200-milligram tablets for dogs
and cats; 1 gram tablet for dogs.
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) For use in dogs as follows:
(i) Indications for use. For the treatment of skin and soft tissue
infections including cellulitis, pyoderma, dermatitis, wound infections,
and abscesses due to susceptible strains of Staphylococcus aureus. For
the treatment of genitourinary tract infections (cystitis) due to
susceptible strains of Escherichia coli, Proteus mirabilis, and
Staphylococcus aureus.
(ii) Amount. Ten milligrams per pound of body weight twice daily.
(iii) Limitations. The drug is administered orally. For skin and
soft tissue infections, treatment should be continued for a minimum of 3
days. For genitourinary tract infections, treatment should be continued
for a minimum of 7 days. Continue treatment at least 48 hours after the
dog has become afebrile or asymptomatic. If no response is seen after 3
days of treatment, therapy should be discontinued and the case
reevaluated. Do not treat for more than 30 days. Safety for use in
pregnant bitches and stud dogs has not been determined. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(2) For use in cats as follows:
[[Page 112]]
(i) Indications for use. For the treatment of skin and soft tissue
infections including abscesses, wound infections, cellulitis, and
dermatitis caused by susceptible strains of Pasteurella multocida,
Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus
spp.
(ii) Amount. Ten milligrams per pound of body weight once daily.
(iii) Limitations. The drug is administered orally. Continue
treatment at least 48 hours after the cat has become afebrile or
asymptomatic. If no response is seen after 3 days of treatment, therapy
should be discontinued and the case reevaluated. Do not treat for more
than 21 days. Safety for use in pregnant cats and breeding male cats has
not been determined. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
[47 FR 41105, Sept. 17, 1982, as amended at 49 FR 43052, Oct. 26, 1984;
51 FR 4165, Feb. 3, 1986; 52 FR 11989, Apr. 14, 1987; 53 FR 27851, July
25, 1988]
Sec. 520.315 Cefadroxil powder for oral suspension.
(a) Specifications. Cefadroxil powder is reconstituted to form a 50
milligram-per-milliliter aqueous suspension.
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) For use in dogs as follows:
(i) Indications for use. For treating genitourinary tract infections
(cystitis) caused by susceptible strains of Escherichia coli, Proteus
mirabilis, and Staphylococcus aureus; and skin and soft tissue
infections including cellulitis, pyoderma, dermatitis, wound infections,
and abscesses caused by susceptible strains of Staphylococcus aureus.
(ii) Amount. 10 milligrams per pound of body weight, twice daily.
(2) For use in cats as follows:
(i) Indications for use. For treating skin and soft tissue
infections including abscesses, wound infections, cellulitis, and
dermatitis caused by susceptible strains of Pasteurella multocida,
Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus
spp.
(ii) Amount. 10 milligrams per pound of body weight, once daily.
(3) Limitations. Discard unused portion of reconstituted product
after 14 days. Treatment should continue for 48 hours after animal is
afebrile or asymptomatic. If no response after 3 days, discontinue
treatment and reevaluate therapy. Not for use in animals raised for food
production. Safe use in pregnant or breeding animals has not been
established. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
[53 FR 27344, July 20, 1988]
Sec. 520.370 Cefpodoxime tablets.
(a) Specifications. Each tablet contains cefpodoxime proxetil
equivalent to 100 or 200 milligrams (mg) cefpodoxime.
(b) Sponsors. See No. 000009 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. 5 to 10 mg per kilogram
(2.3 to 4.5 mg per pound) body weight daily for 5 to 7 days, or for 2 to
3 days beyond the cessation of clinical signs, up to a maximum of 28
days.
(2) Indications for use. For the treatment of skin infections
(wounds and abscesses) caused by susceptible strains of Staphylococcus
intermedius, S. aureus, Streptococcus canis (group G, -hemolytic),
Escherichia coli, Pasteurella multocida, and Proteus mirabilis.
(3) Limitations. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
[69 FR 52815, Aug. 30, 2004]
Sec. 520.390 Chloramphenicol oral dosage forms.
Sec. 520.390a Chloramphenicol tablets.
(a)(1) Specifications. Each tablet contains 100, 250, or 500
milligrams, 1 or 2.5 grams of chloramphenicol.
(2) Sponsor. In Sec. 510.600(c) of this chapter: No. 000010 for
100-, 250-, and 500-milligram and 1-gram tablets; No. 000856 for 100-,
250-. and 500-milligram tablets; No. 017030 for 100-milligram tablets;
No. 000010 for 100-, 250-, and 500-milligram and 1- and 2.5-gram
tablets; No. 000069 for 250-milligram tablets.
(3) Conditions of use. Dogs--(i) Amount. 25 milligrams per pound of
body weight every 6 hours.
[[Page 113]]
(ii) Indications for use. Oral treatment of bacterial pulmonary
infections, bacterial infections of the urinary tract, bacterial
enteritis, and bacterial infections associated with canine distemper
caused by susceptible organisms.
(iii) Limitations. Laboratory tests should be conducted, including
in vitro culturing and susceptibility tests on samples collected prior
to treatment. If no response to chloramphenicol therapy is obtained in 3
to 5 days, discontinue its use and review diagnosis. Not for animals
which are raised for food production. Chloramphenicol products must not
be used in meat-, egg-, or milk-producing animals. The length of time
that residues persist in milk or tissues has not been determined.
Because of potential antagonism, chloramphenicol should not be
administered simultaneously with penicillin or streptomycin. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(b)(1) Specifications. Each tablet contains 50, 100, 250, or 500
milligrams, or 1 gram of chloramphenicol.
(2) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. Dogs--(i) Amount. 25 milligrams per pound of
body weight every 6 hours.
(ii) Indications for use. Oral treatment of bacterial
gastroenteritis associated with bacterial diarrhea, bacterial pulmonary
infections, and bacterial infections of the urinary tract caused by
susceptible organisms.
(iii) Limitations. Laboratory tests should be conducted, including
in vitro culturing and susceptibility tests on samples collected prior
to treatment. If no response is obtained in 3 to 5 days, discontinue use
and reevaluate diagnosis. Not for animals that are raised for food
production. Chloramphenicol products should not be administered in
conjunction with or 2 hours prior to the induction of general anesthesia
with pentobarbital because of prolonged recovery. Chloramphenicol should
not be administered to dogs maintained for breeding purposes. Because of
potential antagonism, chloramphenicol should not be administered
simultaneously with penicillin or streptomycin. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
[57 FR 37323, Aug. 18, 1992, as amended at 62 FR 35076, June 30, 1997;
66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003]
Sec. 520.390b Chloramphenicol capsules.
(a) Specifications. Each capsule contains 50, 100, 250, or 500
milligrams of chloramphenicol.
(b) Sponsor. (1) For chloramphenicol capsules containing 50, 100,
250, or 500 milligrams of chloramphenicol see Nos. 000069, 000185, and
027454 in Sec. 510.600(c) of this chapter.
(2) For chloramphenicol capsules containing 100 or 250 milligrams of
chloramphenicol see No. 058034 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. Dogs--(1) Amount. 25 milligrams per pound of
body weight every 6 hours.
(2) Indications for use. Oral treatment of bacterial pulmonary
infections, bacterial infections of the urinary tract, bacterial
enteritis, and bacterial infections associated with canine distemper
caused by susceptible organisms.
(3) Limitations. Laboratory tests should be conducted including in
vitro culturing and susceptibility tests on samples collected prior to
treatment. This product must not be used in meat-, egg-, or milk-
producing animals. The length of time that residues persist in milk or
tissues has not been determined. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
[57 FR 37323, Aug. 18, 1992, as amended at 63 FR 5255, Feb. 2, 1998]
Sec. 520.390c Chloramphenicol palmitate oral suspension.
(a) Specifications. Each milliliter contains chloramphenicol
palmitate equivalent to 30 milligrams of chloramphenicol.
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. Dogs--(1) Amount. 25 milligrams per pound of
body weight every 6 hours. If no response is obtained in 3 to 5 days,
discontinue use and reevaluate diagnosis.
(2) Indications for use. Treatment of bacterial pulmonary
infections, infections of the urinary tract, enteritis, and infections
associated with canine
[[Page 114]]
distemper that are caused by organisms susceptible to chloramphenicol.
(3) Limitations. Not for use in animals that are raised for food
production. Must not be used in meat-, egg-, or milk-producing animals.
The length of time that residues persist in milk or tissues has not been
determined. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
[57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992]
Sec. 520.420 Chlorothiazide tablets and boluses.
(a)(1) Specifications. Each tablet contains 0.25 gram of
chlorothiazide.
(2) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount. Usual dosage is 5 to 10
milligrams per pound of body weight two or three times daily. \1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(ii) Indications for use. For use in dogs for treatment of
congestive heart failure and renal edema. \1\
(iii) Limitations. (a) Dosage must be adjusted to meet the changing
needs of the individual animal. In mild and responsive cases, it is
suggested that a dose of 5 milligrams per pound of body weight be
administered two or three times daily. In moderately edematous and
moderately responsive animals, a dose of 7.5 to 10 milligrams per pound
of body weight may be administered three times daily. Severe conditions
may require higher doses. Certain animals may respond adequately to
intermittent therapy; in these cases, the drug may be administered
either every other day or for 3 to 5 days each week.
(b) Animals should be regularly and carefully observed for early
signs of fluid and electrolyte imbalance. Take appropriate
countermeasures if this should occur. In some dogs, hypochloremic
alkalosis may occur (that is, excretion of chloride in relation to
sodium is excessive; the plasma bicarbonate level increases and
alkalosis results). Federal law restricts this drug to use by or on the
order of a licensed veterinarian. \1\
(b)(1) Specifications. Each bolus contains 2 grams of
chlorothiazide.
(2) Sponsor. See No. 000006 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount. 2 grams once or twice daily for 3
or 4 days. \1\
(ii) Indications for use. For use in cattle as an aid in reduction
of postparturient udder edema. \1\
(iii) Limitations. Animals should be regularly and carefully
observed for early signs of fluid and electrolyte imbalance. Take
appropriate countermeasures if this should occur. Milk taken from dairy
animals during treatment and for 72 hours (six milkings) after latest
treatment must not be used for food. Federal law restricts this drug to
use by or on the order of a licensed veterinarian. \1\
[43 FR 39085, Sept. 1, 1978, as amended at 62 FR 63270, Nov. 28, 1997]
Sec. 520.434 Chlorphenesin carbamate tablets.
(a) Specifications. Each tablet contains 400 milligrams of
chlorphenesin carbamate.
(b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. 50 milligrams per pound
of body weight on first day; 25 milligrams per pound of body weight each
following day. Divide total daily dose into 2 or 3 equal doses--
administer at 12- or 8-hour intervals.
(2) Indications for use. For use as an adjunct to therapy of acute
inflammatory and traumatic conditions of skeletal muscles. The drug
provides relief of the signs of discomfort associated with myositis,
muscle sprains, traumatic injuries, stifle injuries--especially when
administered before or after surgery--and invertebral disc syndrome (can
be used concurrently with adrenal corticosteroids).
(3) Limitations. Not recommended for pregnant animals or those with
a known hepatic dysfunction. Periodic liver function studies are
recommended for animals on prolonged treatment. If no response is
evident within 5 days of
[[Page 115]]
the beginning of treatment, the diagnosis should be redetermined and
appropriate therapy instituted. Not recommended for use with general
anesthetics other than the barbiturates. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
[44 FR 16009, Mar. 16, 1979]
Sec. 520.445 Chlortetracycline oral dosage forms.
Sec. 520.445a Chlortetracycline bisulfate/sulfamethazine bisulfate
soluble powder.
(a) Specifications. Each pound contains chlortetracycline bisulfate
equivalent to 102.4 grams of chlortetracycline hydrochloride with
sulfamethazine bisulfate equivalent to 102.4 grams of sulfamethazine.
(b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. Sec. 556.150 and 556.670 of this
chapter.
(d) Conditions of use. Swine--Used in drinking water as follows:
(1) Amount. 250 milligrams of chlortetracycline with 250 milligrams
of sulfamethazine per gallon.
(2) Indications for use. Prevention and treatment of bacterial
enteritis; aid in the reduction of the incidence of cervical abscesses;
aid in the maintenance of weight gains in the presence of bacterial
enteritis and atrophic rhinitis.
(3) Limitations. Not to be used for more than 28 consecutive days;
withdraw 15 days before slaughter; as sole source of chlortetracycline
and sulfonamide.
[57 FR 37323, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002]
Sec. 520.445b Chlortetracycline powder (chlortetracycline hydrochloride
or chlortetracycline bisulfate).
(a) Specifications. Chlortetracycline powder contains not less than
15 milligrams per gram chlortetracycline hydrochloride, or
chlortetracycline bisulfate equivalent to 25.6, 64 or 102.4 grams per
pound (56.4, 141 or 225.6 milligrams per gram) chlortetracycline
hydrochloride.
(b) Sponsors. See No. 048164 in Sec. 510.600(c) of this chapter for
conditions of use as in paragraph (d) of this section; No. 053501 for
conditions of use as in paragraph (d)(4) of this section; No. 000010 for
conditions of use as in paragraphs (d)(4)(i)(A) and (B) and (d)(4)(ii)
through (iv) of this section; Nos. 017519 and 059130 for conditions of
use as in paragraphs (d)(4)(i)(A) and (B) and (d)(4)(ii) and (iii) of
this section.
(c) Related tolerances. See Sec. 556.150 of this chapter.
(d) Conditions of use. (1) Use as chlortetracycline hydrochloride in
drinking water as follows:
(i) Swine--(A) Amount. Ten milligrams per pound of body weight daily
in divided doses.
(1) Indications for use. Control and treatment of bacterial
enteritis (scours) caused by Escherichia coli and bacterial pneumonia
associated with Pasteurella spp., Actinobacillus pleuropneumoniae
(Hemophilus spp.), and Klebsiella spp.
(2) Limitations. Prepare a fresh solution twice daily; as sole
source of chlortetracycline; administer for not more than 5 days.
(B) [Reserved]
(ii) [Reserved]
(2) Use as chlortetracycline hydrochloride in a drench or drinking
water as follows:
(i) Calves--(A) Amount. Ten milligrams per pound of body weight
daily in divided doses.
(1) Control and treatment of bacterial enteritis (scours) caused by
E. coli and bacterial pneumonia (shipping fever) associated with
Pasteurella spp., A. pleuropneumoniae (Hemophilus spp.), and Klebsiella
spp.
(2) Limitations. Prepare fresh solution daily; as sole source of
chlortetracycline; administer for not more than 5 days; do not slaughter
animals for food within 24 hours of treatment; do not administer this
product with milk or milk replacers; administer 1 hour before or 2 hours
after feeding milk or milk replacers; a withdrawal period has not been
established in preruminating calves; do not use in calves to be
processed for veal.
(B) [Reserved]
(ii) [Reserved]
(3) [Reserved]
(4) The following uses of chlortetracycline hydrochloride or
chlortetracycline bisulfate in drinking water or
[[Page 116]]
drench were reviewed by the National Academy of Sciences/National
Research Council (NAS/NRC) and found effective:
(i) Chickens--(A) Amount. 200 to 400 milligrams per gallon.
(1) Indications for use. Control of infectious synovitis caused by
Mycoplasma synoviae.
(2) Limitations. Prepare fresh solution daily; as sole source of
chlortetracycline; do not use for more than 14 days; do not slaughter
animals for food within 24 hours of treatment; do not use in laying
chickens.
(B) Amount. 400 to 800 milligrams per gallon.
(1) Indications for use. Control of chronic respiratory disease and
air-sac infections caused by M. gallisepticum and E. coli.
(2) Limitations. Prepare fresh solution daily; as sole source of
chlortetracycline; do not use for more than 14 days; do not slaughter
animals for food within 24 hours of treatment; do not use in laying
chickens.
(C) Amount. One thousand milligrams per gallon.
(1) Indications for use. Control of mortality due to fowl cholera
caused by Pasteurella multocida susceptible to chlortetracycline.
(2) Limitations. See paragraph (d)(4)(i)(A)(2) of this section.
(ii) Growing turkeys--(A) Amount. 400 milligrams per gallon.
(1) Indications for use. Control of infectious synovitis caused by
M. synoviae.
(2) Limitations. Prepare fresh solution daily; as sole source of
chlortetracycline; do not use for more than 14 days; do not slaughter
animals for food within 24 hours of treatment.
(B) Amount. 25 milligrams per pound of body weight daily.
(1) Indications for use. Control of complicating bacterial organisms
associated with bluecomb (transmissible enteritis, coronaviral
enteritis).
(2) Limitations. Prepare fresh solution daily; as sole source of
chlortetracycline; do not use for more than 14 days; do not slaughter
animals for food within 24 hours of treatment.
(iii) Swine--(A) Amount. 10 milligrams per pound body weight daily
in divided doses.
(B) Indications for use. Control and treatment of bacterial
enteritis (scours) caused by E. coli and Salmonella spp. and bacterial
pneumonia associated with Pasteurella spp., Actinobacillus
pleuropneumoniae (Hemophilus spp.), and Klebsiella spp.
(C) Limitations. Prepare fresh solution daily; as sole source of
chlortetracycline; do not use for more than 5 days; for 000010 and
017519 do not slaughter animals for food within 5 days of treatment; for
053501 do not slaughter animals for food within 24 hours of treatment.
(iv) Calves, beef cattle, and nonlactating dairy cattle--(A) Amount.
10 milligrams per pound daily in divided doses.
(B) Indications for use. Control and treatment of bacterial
enteritis (scours) caused by E. coli and Salmonella spp. and bacterial
pneumonia (shipping fever complex) associated with Pasteurella spp., A.
pleuropneumoniae (Hemophilus spp.), and Klebsiella spp.
(C) Limitations. Prepare fresh solution daily; use as a drench; as
sole source of chlortetracycline; do not use for more than 5 days; do
not slaughter animals for food within 24 hours of treatment; do not use
in lactating cattle; do not administer this product with milk or milk
replacers; administer 1 hour before or 2 hours after feeding milk or
milk replacers; a withdrawal period has not been established in
preruminating calves; do not use in calves to be processed for veal.
[57 FR 37324, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 61015,
Nov. 19, 1993; 59 FR 39439, Aug. 3, 1994; 60 FR 26827, May 19, 1995; 60
FR 47052, Sept. 11, 1995; 62 FR 27691, May 21, 1997; 62 FR 35076, June
30, 1997; 62 FR 60656, Nov. 12, 1997; 64 FR 37673, July 13, 1999; 65 FR
10706, Feb. 29, 2000; 66 FR 35898, July 10, 2001; 67 FR 78355, Dec. 24,
2002; 69 FR 62406, Oct. 26, 2004]
Sec. 520.445c Chlortetracycline tablets and boluses.
(a) Specifications. Each tablet/bolus contains 25, 250, or 500
milligrams of chlortetracycline hydrochloride.
(b) Sponsors. See No. 000010 in Sec. 510.600(c) of this chapter for
the 250-milligram chlortetracycline hydrochloride bolus; see No. 053501
for the 25-milligram tablet and the 500 milligram bolus.
[[Page 117]]
(c) Related tolerances. See Sec. 556.150 of this chapter.
(d) National Academy of Sciences/National Research Council NAS/NRC)
status. The conditions of use specified in this section were NAS/NRC
reviewed and found effective. Applications for these uses need not
include effectiveness data as specified in Sec. 514.111 of this chapter
but may require bioequivalency and safety information.
(e) Conditions of use. Calves--(1) Amount. One 250 milligram bolus
per 50 pounds of body weight twice a day for 3 to 5 days.
(i) Indications for use. Treatment of bacterial enteritis (scours)
caused by Escherichia coli and bacterial pneumonia associated with
Pasteurella spp., Klesbsiella spp., and Hemophilus spp.
(ii) Limitations. Administer bolus directly by mouth or crush and
dissolve in milk or water for drenching or bucket feeding; if no
improvement is noted after 3 days of treatment, consult a veterinarian;
do not use for more than 5 days; do not administer within 24 hours of
slaughter.
(2) Amount. One 25 milligram tablet for each 5 pounds of body weight
every 12 hours daily for 3 to 5 days.
(i) Indications for use. Control and treatment of bacterial
enteritis (scours) caused by E. coli and Salmonella spp. and bacterial
pneumonia associated with Pasteurella spp., Hemophilus spp., and
Klebsiella spp., susceptible to chlortetracycline.
(ii) Limitations. Administer tablet directly by mouth or crush and
dissolve in water for drenching; if no improvement is noted after 3 days
of treatment, consult a veterinarian; do not use for more than 5 days;
when feeding milk or milk replacer, administration 1 hour before or 2
hours after feeding; do not administer within 24 hours of slaughter.
(3) Amount. One 500 milligram bolus per 100 pounds of body weight
twice a day for 3 to 5 days.
(i) Indications for use. Treatment of bacterial enteritis (scours)
caused by E. coli and Salmonella spp., and bacterial pneumonia
associated with Pasteurella spp., Hemophilus spp., and Klebsiella spp.,
susceptible to chlortetracycline.
(ii) Limitations. Administer directly by mouth or crush and dissolve
in water for drenching; if no improvement is noted after 3 days of
treatment, consult a veterinarian; do not use for more than 5 days; do
not administer within 24 hours of slaughter.
[57 FR 37325, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002]
Sec. 520.446 Clindamycin capsules and tablets.
(a) Specifications--(1) Each capsule contains the equivalent of 25,
75, 150, or 300 milligrams (mg) clindamycin as the hydrochloride salt.
(2) Each tablet contains the equivalent of 25, 75, or 150 mg
clindamycin as the hydrochloride salt.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as
follows:
(1) Nos. 000009 and 059130 for use of capsules described in
paragraph (a)(1) of this section as in paragraphs (d)(1)(i) and
(d)(2)(i) of this section.
(2) No. 051311 for use of tablets described in paragraph (a)(2) of
this section as in paragraphs (d)(1)(ii) and (d)(2)(ii) of this section.
(c) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(d) Conditions of use in dogs--(1) Amount--(i) Wounds, abscesses,
and dental infections: 2.5 to 15 mg per pound (/lb) of body weight every
12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb of
body weight every 12 hours for a minimum of 28 days.
(ii) Wounds, abscesses, and dental infections: 2.5 mg/lb of body
weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 mg/lb
of body weight every 12 hours for a minimum of 28 days.
(2) Indications for use--(i) For the treatment of skin infections
(wounds and abscesses) due to susceptible strains of coagulase-positive
staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and
abscesses due to susceptible strains of Bacteroides fragilis, Prevotella
melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens,
dental infections due to susceptible strains of S. aureus, B. fragilis,
P. melaninogenicus, F. necrophorum, and C. perfringens, and
osteomyelitis due to susceptible strains
[[Page 118]]
of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C.
perfringens.
(ii) For the treatment of soft tissue infections (wounds and
abscesses), dental infections, and osteomyelitis caused by susceptible
strains of S. aureus, soft tissue infections (deep wounds and
abscesses), dental infections, and osteomyelitis caused by or associated
with susceptible strains of B. fragilis, P. melaninogenicus, F.
necrophorum, and C. perfringens.
[67 FR 54954, Aug. 27, 2002, as amended at 68 FR 55824, Sept. 29, 2003;
69 FR 32273, June 9, 2004]
Sec. 520.447 Clindamycin liquid.
(a) Specifications. Each milliliter of solution contains the
equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as
follows:
(1) Nos. 000009 and 059130 for use as in paragraphs (d)(1)(i)(A),
(d)(1)(ii)(A), (d)(2)(i)(A), and (d)(2)(ii)(A) of this section.
(2) No. 059079 for use as in paragraphs (d)(1)(i)(B), (d)(1)(ii)(B),
(d)(2)(i)(B), and (d)(2)(ii)(B) of this section.
(c) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(d) Conditions of use--(1) Dogs--(i) Amount--(A) Wounds, abscesses,
and dental infections: 2.5 to 15 mg per pound (/lb) of body weight every
12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb of
body weight every 12 hours for a minimum of 28 days.
(B) Wounds, abscesses, and dental infections: 2.5 mg per pound (/lb)
of body weight every 12 hours for a maximum of 28 days. Osteomyelitis:
5.0 mg/lb of body weight every 12 hours for a minimum of 28 days.
(ii) Indications for use--(A) For the treatment of skin infections
(wounds and abscesses) due to susceptible strains of coagulase-positive
staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and
abscesses due to susceptible strains of Bacteroides fragilis, Prevotella
melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens,
dental infections due to susceptible strains of S. aureus, B. fragilis,
P. melaninogenicus, F. necrophorum, and C. perfringens, and
osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P.
melaninogenicus, F. necrophorum, and C. perfringens.
(B) For the treatment of soft tissue infections (wounds and
abscesses), dental infections, and osteomyelitis caused by susceptible
strains of S. aureus and for soft tissue infections (deep wounds and
abscesses), dental infections, and osteomyelitis caused by or associated
with susceptible strains of B. fragilis, P. melaninogenicus, F.
necrophorum, and C. perfringens.
(2) Cats--(i) Amount--(A) 5.0 to 15.0 mg/lb of body weight every 24
hours for a maximum of 14 days.
(B) 5.0 to 10.0 mg/lb of body weight every 24 hours for a maximum of
14 days.
(ii) Indications for use--(A) For the treatment of skin infections
(wounds and abscesses) due to susceptible strains of S. aureus, S.
intermedius, Streptococcus spp., deep wounds and abscesses due to
susceptible strains of Clostridium perfringens and Bacteroides fragilis,
and dental infections due to susceptible strains of S. aureus, S.
intermedius, Streptococcus spp., C. perfringens, and B. fragilis.
(B) Aerobic bacteria: Treatment of soft tissue infections (wounds
and abscesses) and dental infections caused by or associated with
susceptible strains of S. aureus, S. intermedius, and Streptococcus spp.
Anaerobic bacteria: Treatment of soft tissue infections (deep wounds and
abscesses) and dental infections caused by or associated with
susceptible strains of C. perfringens and B. fragilis.
[67 FR 54954, Aug. 27, 2002, as amended at 67 FR 78684, Dec. 26, 2002;
68 FR 55824, Sept. 29, 2003; 69 FR 31734, June 7, 2004]
Sec. 520.452 Clenbuterol syrup.
(a) Specifications. Each milliliter contains 72.5 micrograms of
clenbuterol hydrochloride.
(b) Sponsor. See 000010 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use--(1) Horses--(i) Amount. Administer orally
twice a day (b.i.d.). Initial dose is 0.5 milliliter per
[[Page 119]]
100 pounds body weight (0.8 micrograms per kilogram) for 3 days (6
treatments). If no improvement, administer 1 milliliter per 100 pounds
(1.6 micrograms per kilogram) for 3 days (6 treatments). If no
improvement, administer 1.5 milliliters per 100 pounds (2.4 micrograms
per kilogram) for 3 days (6 treatments). If no improvement, administer
2.0 milliliters per 100 pounds (3.2 micrograms per kilogram) for 3 days
(6 treatments). If no improvement, horse is nonresponder to clenbuterol
and treatment should be discontinued.
(ii) Indications for use. Indicated for the management of horses
affected with airway obstruction, such as occurs in chronic obstructive
pulmonary disease (COPD).
(iii) Limitations. Treat at effective dose for 30 days. At the end
of the 30-day treatment period, drug should be withdrawn. If signs
return, the 30-day treatment period may be repeated. If repeating
treatment, the step-wise dosage schedule should be repeated. The effect
of this drug on breeding stallions and brood mares has not been
determined. Treatment starting with dosages higher than the initial dose
is not recommended. Federal law prohibits the extralabel use of this
drug in food animals. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) [Reserved]
[63 FR 41419, Aug. 4, 1998]
Sec. 520.455 Clomipramine hydrochloride tablets.
(a) Specifications. Each tablet contains 20, 40, or 80 milligrams of
clomipramine hydrochloride.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. 2 to 4 milligrams of clomipramine
hydrochloride per kilogram (0.9 to 1.8 milligrams per pound) of body
weight per day, administered as a single daily dose or divided twice
daily.
(2) Indications for use. For use as part of a comprehensive
behavioral management program to treat separation anxiety in dogs
greater than 6 months of age.
(3) Limitations. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
[64 FR 1762, Jan. 12, 1999]
Sec. 520.462 Clorsulon drench.
(a) Specifications. The drug is a suspension containing 8.5 percent
clorsulon (85 milligrams per milliliter).
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. Cattle--(1) Amount. One-quarter fluid ounce
per 200 pounds of body weight (7 milligrams per kilogram or 3.2
milligrams per pound of body weight).
(2) Indications for use. For the treatment of immature and adult
liver fluke (Fasciola hepatica) infestations in cattle.
(3) Limitations. Using dose syringe, deposit drench over back of
tongue. Do not treat cattle within 8 days of slaughter. Because a
withdrawal time in milk has not been established, do not use in female
dairy cattle of breeding age. Consult your veterinarian for assistance
in the diagnosis, treatment, and control of parasitism.
[50 FR 10221, Mar. 14, 1985, as amended at 62 FR 63270, Nov. 28, 1997]
Sec. 520.522 Cyclosporine.
(a) Specifications. Each capsule contains 10, 25, 50, or 100
milligrams (mg) cyclosporine.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use in dogs--(1) Amount. 5 mg per kilogram of body
weight given orally as a single daily dose for 30 days. Following this
initial daily treatment period, the dosage may be tapered by decreasing
the frequency of administration to every other day or two times a week,
until a minimum frequency is reached which will maintain the desired
therapeutic effect.
(2) Indications for use. For the control of atopic dermatitis in
dogs weighing at least 4 pounds body weight.
(3) Limitations. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
[68 FR 54804, Sept. 19, 2003]
[[Page 120]]
Sec. 520.530 Cythioate oral liquid.
(a) Specifications. Each milliliter contains 15 milligrams of
cythioate.
(b) Sponsor. See Nos. 000859 and 053501 in Sec. 510.600 of this
chapter.
(c) Special considerations. Cythioate is a cholinesterase inhibitor.
Do not use this product in animals simultaneously with or within a few
days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, insecticides, pesticides, or chemicals.
(d) Conditions of use--(1) Amount. 15 milligrams cythioate per 10
pounds of body weight every third day or twice a week.
(2) Indications for use. Dogs, for control of fleas.
(3) Limitations. For oral use in dogs only. Do not use in greyhounds
or in animals that are pregnant, sick, under stress, or recovering from
surgery. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[49 FR 5614, Feb. 14, 1984, as amended at 67 FR 78355, Dec. 24, 2002]
Sec. 520.531 Cythioate tablets.
(a) [Reserved]
(b) Sponsors. See No. 000859 in Sec. 510.600(c) of this chapter for
use of 30- and 90-milligram (mg) tablets and see No. 053501 in Sec.
510.600(c) of this chapter for use of 30-mg tablet.
(c) Special considerations. Cythioate is a cholinesterase inhibitor.
Do not use this product in animals simultaneously with or within a few
days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, insecticides, pesticides, or chemicals.
(d) Conditions of use--(1) Amount. 30 milligrams cythioate per 20
pounds of body weight every third day or twice a week.
(2) Indications for use. Dogs, for control of fleas.
(3) Limitations. For oral use in dogs only. Do not use in greyhounds
or in animals that are pregnant, sick, under stress, or recovering from
surgery. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[49 FR 5615, Feb. 14, 1984, as amended at 59 FR 26942, May 25, 1994; 67
FR 78355, Dec. 24, 2002]
Sec. 520.534 Decoquinate.
(a) Specifications. The drug is a powder containing 0.8 percent
decoquinate.
(b) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.170 of this chapter.
(d) Conditions of use. Calves--(1) Amount. Feed 22.7 milligrams per
100 pounds of body weight (0.5 milligram per kilogram) per day.
(2) Indications for use. For the prevention of coccidiosis in
ruminating and nonruminating calves, including veal calves, caused by
Eimeria bovis and E. zuernii.
(3) Limitations. Feed in whole milk at the rate of 22.7 milligrams
per 100 pounds body weight daily (0.5 milligram per kilogram) for at
least 28 days.
[64 FR 10103, Mar. 2, 1999, as amended at 64 FR 30386, June 8, 1999]
Sec. 520.538 Deracoxib.
(a) Specifications. Each chewable tablet contains 25 or 100
milligrams (mg) deracoxib.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use in dogs--(1) Amount. Administer orally as
needed, as a single daily dose based on body weight.
(i) 1 to 2 mg/kilograms (kg) (0.45 to 0.91 mg/pound (lb), for use as
in paragraph (d)(2)(i) of this section.
(ii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as in
paragraph (d)(2)(ii) of this section.
(2) Indications for use. (i) For the control of pain and
inflammation associated with osteoarthritis.
(ii) For the control of postoperative pain and inflammation
associated with orthopedic surgery in dogs weighing 4 or more pounds
(1.8 kg).
(3) Limitations. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
[67 FR 68760, Nov. 13, 2002, as amended at 68 FR 18882, Apr. 17, 2003]
[[Page 121]]
Sec. 520.540 Dexamethasone oral dosage forms.
Sec. 520.540a Dexamethasone powder.
(a) Specifications. Dexamethasone powder is packaged in packets
containing 10 milligrams of dexamethasone.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) Dexamethasone powder is indicated in
cases where cattle and horses require additional steroid therapy
following its parenteral administration. The drug is used as supportive
therapy for management or inflammatory conditions such as acute
arthritic lameness, and for various stress conditions where
corticosteroids are required while the animal is being treated for a
specific condition.
(2) The drug is administered at a dosage level of 5 to 10 milligrams
per animal the first day then 5 milligrams per day as required by drench
or by sprinkling on a small amount of feed.
(3) Clinical and experimental data have demonstrated that
corticosteroids administered orally or parenterally to animals may
induce the first stage of parturition when administered during the last
trimester of pregnancy and may precipitate premature parturition
followed by dystocia, fetal death, retained placenta, and metritis.
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 13838, Mar. 27, 1975; 41 FR 9149, Mar. 3, 1976; 52 FR 7832, Mar.
13, 1987]
Sec. 520.540b Dexamethasone tablets and boluses.
(a)(1) Specifications. Each bolus is half-scored and contains 10
milligrams of dexamethasone.
(2) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) Dexamethasone bolus is indicated in cases
where cattle and horses require additional steroid therapy following its
parenteral administration. The drug may be used as supportive therapy
for management of inflammatory conditions such as acute arthritic
lamenesses, and for various stress conditions where corticosteroids are
required while the animal is being treated for a specific condition.
(ii) Administered orally, 5 to 10 milligrams for the first day, then
5 milligrams per day as required.
(iii) Do not use in viral infections during the viremic stage. With
bacterial infections, appropriate antibacterial therapy should be used.
(iv) Do not use in animals with chronic nephritis and
hypercorticalism (cushingoid syndrome), except for emergency therapy.
(v) Clinical and experimental data have demonstrated that
corticosteroids administered orally or by injection to animals may
induce the first stage of parturition when administered during the last
trimester of pregnancy and may precipitate premature parturition
followed by dystocia, fetal death, retained placenta, and metritis.
(vi) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(b)(1) Specifications. Each tablet contains 0.25 milligram of
dexamethasone.\1\
(2) Sponsors. See Nos. 000061 and 061623 in Sec. 510.600(c) of this
chapter.
(3) Conditions of use--(i) Amount. Dogs: Administer orally at 0.25
to 1.25 milligrams per day for up to 7 days. Cats: 0.125 to 0.5
milligram per day for up to 7 days.\1\
(ii) Indications for use. In treatment of dogs and cats as an anti-
inflammatory agent.\1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter.
---------------------------------------------------------------------------
(iii) Limitations. (a) Clinical and experimental data have
demonstrated that corticosteriods administered orally or by injection to
animals may induce the first stage of parturition when administered
during the last trimester of pregnancy; and they may precipitate
premature parturition followed by dystocia, fetal death, retained
placenta, and metritis.
(b) Do not use in viral infections. Anti-inflammatory action of
corticosteroids may mask signs of infections. Do not use in animals with
tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers,
except for emergency therapy.\1\
[[Page 122]]
(c) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.\1\
[40 FR 26273, June 23, 1975, as amended at 44 FR 7130, Feb. 6, 1979; 50
FR 49372, Dec. 2, 1985; 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8,
1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003]
Sec. 520.540c Dexamethasone chewable tablets.
(a) Specifications. Each half-scored tablet contains 0.25 milligram
of dexamethasone.\1\
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. 0.25 to 1.25 milligrams per
day.\1\
(2) Indications for use. Supportive therapy in nonspecific
dermatosis and inflammatory conditions in dogs.\1\
(3) Limitations. (i) Administer by free-choice feeding or crumble
over food. Administer 0.25 to 1.25 milligrams daily in single or two
divided doses until response is noted or 7 days have elapsed. When
response is attained, dosage should be gradually reduced by 0.125
milligram per day until maintenance level is achieved.
(ii) Clinical and experimental data have demonstrated that
corticosteriods administered orally or parenterally to animals may
induce the first stage of parturition when administered during the last
trimester of pregnancy; and they may precipitate premature parturition
followed by dystocia, fetal death, retained placenta, and metritis.
(iii) Do not use in viral infections. Anti-inflammatory action of
corticosteriods may mask signs of infection. Do not use in animals with
tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers,
except for emergency therapy.\1\
(iv) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[44 FR 7130, Feb. 6, 1979, as amended at 56 FR 50653, Oct. 8, 1991; 60
FR 55659, Nov. 2, 1995]
Sec. 520.550 Dextrose/glycine/electrolyte.
(a) Specifications. The product is distributed in packets each of
which contains the following ingredients: sodium chloride 8.82 grams,
potassium phosphate 4.20 grams, citric acid anhydrous 0.5 gram,
potassium citrate 0.12 gram, aminoacetic acid (glycine) 6.36 grams, and
dextrose 44.0 grams.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) Dextrose/glycine/electrolyte is indicated
for use in the control of dehydration associated with diarrhea (scours)
in calves. It is used as an early treatment at the first signs of
scouring. It may also be used as followup treatment following
intravenous fluid therapy.
(2) Dissolve each packet in two quarts of warm water and administer
to each calf as follows:
(i) Scouring and/or dehydrated calves. Feed 2 quarts of solution,
twice daily for 2 days (four feedings). No milk or milk replacer should
be fed during this period. For the next four feedings (days 3 and 4),
use 1 quart of solution together with 1 quart of milk replacer.
Thereafter, feed as normal.
(ii) Newly purchased calves. Feed 2 quarts of solution instead of
milk as the first feed upon arrival. For the next scheduled feeding, use
1 quart of solution mixed together with 1 quart of milk or milk
replacer. Thereafter, feed as normal.
(3) The product should not be used in animals with severe
dehydration (down, comatose, or in a state of shock). Such animals need
intravenous therapy. Oral therapy in these cases is too slow. Animals
which cannot drink after initial intravenous therapy may need to be
dosed with a stomach tube or esophageal tube. Adequate colostrum intake
during the first 12 hours is essential for healthy, vigorous calves.
Antibacterial therapy is often indicated in bacterial scours due to E.
coli and/or Salmonella. The product does not contain antibacterial
agents. A veterinarian should be consulted in severely scouring calves
or cases requiring antibacterial therapy. The product is not
nutritionally complete if administered by itself for long periods of
time. It should not be administered beyond the recommended treatment
period without the addition of milk or milk replacer.
[48 FR 38606, Aug. 25, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 60
FR 55659, Nov. 2, 1995]
[[Page 123]]
Sec. 520.563 Diatrizoate meglumine and diatrizoate sodium oral solution.
(a) Specifications. Diatrizoate meglumine oral solution is a water
soluble radiopaque medium containing 66 percent diatrizoate meglumine
and 10 percent diatrizoate sodium.
(b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is indicated for radiography of the
gastrointestinal tract in dogs and cats.
(2) It is administered orally at a dosage level of 0.5 to 1.0
milliliter per pound of body weight by gavage or stomach tube. It is
administered rectally at a dosage level of 0.5 to 1.0 milliliter per
pound of body weight diluted with 1 part of the drug to 5 parts of
water.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[44 FR 12993, Mar. 9, 1979, as amended at 50 FR 41489, Oct. 11, 1985]
Sec. 520.580 Dichlorophene and toluene capsules.
(a) Specifications. Each soft gelatin capsule contains 50 milligrams
of dichlorophene and 60 milligrams of toluene or multiples thereof.
(b) Sponsor. (1) For single dose only, see 000010, 000061, 000115,
000842, 010237, 017135, 023851, 049968, 051311, and 058670 in Sec.
510.600(c) of this chapter.
(2) For single and multiple dose, see 000010, 000061, and 038782 in
Sec. 510.600(c) of this chapter.
(c) Required statement. Consult your veterinarian for assistance in
the diagnosis, treatment, and control of parasitism, and before
administering to weak or debilitated animals.
(d) Conditions of use--(1) Amount. (i) Single dose of 100 milligrams
of dicholorophene and 120 milligrams of toluene per pound of body
weight.
(ii) Divided dose of 100 milligrams of dichlorophene and 120
milligrams of toluene per 5 pounds of body weight (20 and 24 milligrams
per pound) daily for 6 days.
(2) Indications for use. It is used for the removal of ascarids
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma
caninum and Uncinaria stenocephala) and as an aid in removing tapeworms
(Taenia pisiformis, Dipylidium caninum, and Echinococcus granulosus)
from dogs and cats.
(3) Limitations. Withhold solid foods and milk for at least 12 hours
prior to medication and for 4 hours afterward. Repeat treatment in 2 to
4 weeks in animals subject to reinfection.
[45 FR 10332, Feb. 15, 1980]
Editorial Note: For Federal Register citations affecting Sec.
520.580, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.
Sec. 520.581 Dichlorophene tablets.
(a) Specifications. Each tablet contains 1 gram of dichlorophene.
(b) Sponsor. See 023851 in Sec. 510.600(c) of this chapter.
(c) Required statement. Consult your veterinarian for assistance in
the diagnosis, treatment, and control of parasitism, and before
administering to weak or debilitated animals.
(d) Conditions of use. Dogs--(1) Amount. Single dose of 1 tablet (1
gram of dichlorophene) for each 10 pounds of body weight.
(2) Indications for use. It is used as an aid in the removal of
tapeworms (Taenia pisiformis and Dipylidium caninum).
(3) Limitations. Withhold solid foods and milk for at least 12 hours
prior to medication and for 4 hours afterward.
[45 FR 10333, Feb. 15, 1980]
Sec. 520.600 Dichlorvos.
(a) Chemical name. 2,2-Dichlorvinyl dimethyl phosphate.
(b) [Reserved]
(c) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(d) Related tolerances. See Sec. 556.180 of this chapter.
(e) Conditions of use in swine. (1) It is recommended for the
removal and control of sexually mature (adult), sexually immature and/or
4th stage larvae of the whipworm (Trichuris suis), nodular worms
(Oesophagostomum spp.), large round-worm (Ascaris suum), and the mature
thick stomach worm (Ascarops strongylina) occurring in the lumen of the
gastrointestinal tract of pigs, boars, and open or bred gilts and sows.
[[Page 124]]
(2) The preparation should be added to the indicated amount of feed
as set forth in paragraph (e)(2) of this section and administered
shortly after mixing, as follows:
------------------------------------------------------------------------
Pounds of
Pounds of mixed feed Number of
feed to be to be pigs to be
Weight of animal in pounds mixed with administered treated
each 0.08 to each pig per 0.08
ounce of as a single ounce of
dichlorvos treatment dichlorvos
------------------------------------------------------------------------
20-30............................. 4 0.33 12
31-40............................. 5 0.56 9
41-60............................. 6 1.00 6
61-80............................. 5 1.00 5
81-100............................ 4 1.00 4
Adult Gilts, Sows, and Boars...... 16 4.00 4
------------------------------------------------------------------------
(3) Do not use this product on animals either simultaneously or
within a few days before or after treatment with or exposure to
cholinesterase inhibiting drugs, pesticides, or chemicals. The
preparation should be mixed thoroughly with the feed on a clean,
impervious surface. Do not allow swine access to feed other than that
containing the preparation until treatment is complete. Do not treat
pigs with signs of scours until these signs subside or are alleviated by
proper medication. Resume normal feeding schedule afterwards. Swine may
be retreated in 4 to 5 weeks.
(f) Conditions of use in dogs. (1) For removal of Toxocara canis and
Toxascaris leonina (roundworms), Ancylostoma caninum and Uncinaria
stenocephala (hookworms), and Trichuris vulpis (whipworm) residing in
the lumen of the gastrointestinal tract.
(2) The drug is in capsule form for direct administration and in
pellet form for administration in about one-third of the regular canned
dog food ration or in ground meat. Dogs may be treated with any
combination of capsules and/or pellets so that the animal receives a
single dose equaling 12 to 15 milligrams of the active ingredient per
pound of body weight. One-half of the single recommended dosage may be
given, and the other half may be administered 8 to 24 hours later. This
split dosage schedule should be used in animals which are very old,
heavily parasitized, anemic, or otherwise debilitated. The drug should
not be used in dogs weighing less than 2 pounds.
(3) In some dogs, efficacy against Trichurias vulpis (whipworm) may
be erratic. Dogs that do not develop a negative stool for Trichuris
vulpis ova 10 to 14 days following initial treatment should be re-
treated. If a negative stool is not obtained in 10 to 14 days following
re-treatment, alternate means of therapy should be considered.
(4) Do not use in dogs infected with Dirofilaria immitis.
(5) Do not use with other anthelmintics, taeniacides, antifilarial
agents, muscle relaxants, or tranquilizers.
(6) The drug is a cholinesterase inhibitor. Not for use
simultaneously or within a few days before or after treatment with or
exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.
(7) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(g) Conditions of use in horses when administered in grain. (1) It
is recommended for the removal and control of bots (Gastrophilus
intestinalis, G. nasalis), large strongyles (Strongylus vulgaris, S.
equinus, S. edentatus), small strongyles (of the genera Cyathostomum,
Cylicocercus, Cylicocyclus, Cylicodontophorus, Triodontophorus,
Poteriostomum, Gyalocephalus), pinworms (Oxyuris equi), and large
roundworm (Parascaris equorum) in horses including ponies and mules. Not
for use in foals (sucklings and young weanlings).
(2) For a satisfactory diagnosis, a microscopic fecal examination
should be performed by a veterinarian or a diagnostic laboratory prior
to worming.
(3) It is administered in the grain portion of the ration at a
dosage of 14.2 milligrams to 18.5 milligrams per pound of body weight as
a single dose. It may be administered at one-half of the single
recommended dosage and repeated 8 to 12 hours later in the treatment of
very aged, emaciated or debilitated subjects or those reluctant to
consume medicated feed. In suspected cases of severe ascarid infection
sufficient to cause concern over mechanical blockage of the intestinal
tract, the split dosage should be utilized.
[[Page 125]]
(4) Do not use in horses which are severely debilitated, suffering
from diarrhea or severe constipation, infectious disease, toxemia or
colic. Do not administer in conjunction with or within 1 week of
administration of muscle relaxant drugs, phenothiazine derived
tranquilizers or central nervous system depressant drugs. Horses should
not be subjected to insecticide treatment for 5 days prior to or after
treating with the drug. Do not administer to horses afflicted with
chronic alveolar emphysema (heaves) or related respiratory conditions.
The product is a cholinesterase inhibitor and should not be used
simultaneously or within a few days before or after treatment with or
exposure to cholinesterase inhibiting drugs, pesticides or chemicals.
(5) Do not use in animals other than horses, ponies, and mules. Do
not use in horses, ponies, and mules intended for food purposes. Do not
allow fowl access to feed containing this preparation or to fecal
excrement from treated animals.
(h) Conditions of use in horses when administered orally by syringe.
(1) It is recommended for the removal and control of first, second, and
third instar bots (Gastrophilus intestinalis and G. nasalis), sexually
mature and sexually immature (4th stage) ascarids (Parascaris equorum)
in horses and foals.
(2) The product is in the form of a gel which is administered
directly from a syringe onto the horse's tongue. The product is
administered at a dosage level of 20 milligrams of dichlorvos per
kilogram of body weight for the removal of bots and ascarids. The same
dosage level is repeated every 21 to 28 days for the control of bots and
ascarids. For the control of bots only, the repeat dosage is 10
milligrams per kilogram of body weight every 21 to 28 days during bot
fly season.
(3) Do not use this product in animals simultaneously or within a
few days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, pesticides or chemicals. Do not administer in
conjunction with or within 1 week of administration of muscle-relaxant
drugs, phenothiazine derived tranquilizers, or central nervous system
depressants.
(4) Do not use in horses which are severly debilitated or suffering
from diarrhea or severe constipation, infectious disease, toxemia, or
colic. Do not administer to horses affected with chronic alveolar
emphysema (heaves) or other respiratory conditions.
(5) Do not use in horses intended for food purposes.
(6) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(i) Conditions of use in dogs, cats, puppies, and kittens. (1) Each
tablet contains 2, 5, 10, or 20 milligrams of dichlorvos.
(2) It is administered orally at 5 milligrams of dichlorvos per
pound of body weight.
(3) Dogs and puppies: Removal and control of intestinal roundworms
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma
caninum and Uncinaria stenocephala).
(4) Cats and kittens: Removal and control of intestinal roundworms
(Toxocara cati and Toxascaris leonina) and hookworms (Ancylostoma
tubaeforme and Uncinaria stenocephala).
(5) Dichlorvos is a cholinesterase inhibitor. Do not use
simultaneously with or within a few days before or after treatment with
or exposure to cholinesterase-inhibiting drugs, pesticides, or
chemicals.
(6) Do not use in animals under 10 days of age or 1 pound of body
weight.
(7) Do not administer to animals showing signs of constipation,
mechanical blockage of the intestinal tract, impaired liver function, or
recently exposed to or showing signs of infectious disease.
(8) Do not use in dogs or puppies infected with Dirofilaria immitis.
(9) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 13838, Mar. 27, 1975, as amended at 48 FR 40704, Sept. 9, 1983;
51 FR 28546, Aug. 8, 1986; 62 FR 35076, June 30, 1997; 64 FR 18571, Apr.
15, 1999]
Sec. 520.608 Dicloxacillin sodium monohydrate capsules.
(a) Specifications. Each capsule contains dicloxacillin sodium
monohydrate equivalent to 50, 100, 200, or 500 milligrams of
dicloxacillin.
[[Page 126]]
(b) Sponsor. See No. 000856 in Sec. 510.600 (c) of this chapter.
(c) Conditions of use. Dogs--(1) Amount. 5 to 10 milligrams per
pound of body weight, three times daily. In severe cases, up to 25
milligrams per pound of body weight three times daily.
(2) Indications for use. Treatment of pyoderma (pyogenic dermatitis)
due to penicillinase-producing staphylococci sensitive to the drug.
(3) Limitations. For the treatment of dogs only. Continue treatment
for 24 to 48 hours after the animal has become afebrile or asymptomatic,
Administer 1 to 2 hours before feeding to ensure maximum absorption. Not
for use in animals which are raised for food production. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[57 FR 37325, Aug. 18, 1992]
Sec. 520.620 Diethylcarbamazine oral dosage forms.
Sec. 520.622 Diethylcarbamazine citrate oral dosage forms.
Sec. 520.622a Diethylcarbamazine citrate tablets.
(a) Sponsors. (1) See 015579 in Sec. 510.600(c) of this chapter for
use of 50, 200, and 400 milligram tablets for prevention of heartworm
disease in dogs and as an aid in the treatment of ascarid infections in
dogs and cats.
(2) See 053501 in Sec. 510.600(c) of this chapter for use of 100,
200, and 300 milligram tablets for prevention of heartworm disease in
dogs and as an aid in the treatment of ascarid infections in dogs.
(3) See 061623 in Sec. 510.600(c) of this chapter for use of 50,
100, 200, 300, or 400 milligram tablets for prevention of heartworm
disease in dogs, as an aid in the control of ascarid infections in dogs,
and as an aid in the treatment of ascarid infections in dogs and cats.
(4) See 017030 in Sec. 510.600(c) of this chapter for use of 50,
100, 200, 300, and 400 milligram tablets for prevention of heartworm
disease in dogs and as an aid in the treatment of ascarid infections in
dogs and cats.
(5) See 000081 in Sec. 510.600(c) of this chapter for use of 60,
120, or 180 milligram tablets for prevention of heartworm disease in
dogs, as an aid in the control of ascarid infections in dogs, and as an
aid in the treatment of ascarid infections in dogs and cats.
(6) See No. 000010 in Sec. 510.600(c) of this chapter for use of
50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm
disease in dogs, as an aid in the control of ascarid infections in dogs,
and as an aid in the treatment of ascarid infections in dogs and cats.
(b) Conditions of use--(1) Dosage/indications for use. (i) Three
milligrams per pound of body weight daily for prevention of heartworm
disease (Dirofilaria immitis) in dogs.
(ii) Three milligrams per pound of body weight daily as an aid in
the control of ascarid infections (Toxocara canis) in dogs.
(iii) Twenty-five to 50 milligrams per pound of body weight as an
aid in the treatment of ascarid infections in dogs (Toxocara canis) and
cats (Toxocara canis and Toxascaris leonina).
(2) Limitations. Administer orally either pulverized and given in
feed or water or directly by mouth. For the treatment of ascarid
infections, repeat in 10 to 20 days to remove immature worms that may
enter the intestine from the lungs after the first dose. Do not treat
dogs with established heartworm infections until they have been
converted to a negative status by the use of adulticidal and
microfilaricidal drugs. Inadvertent administration to heartworm-infected
dogs may cause adverse reactions because of pulmonary occlusion.
Overdosage may cause emesis. For prevention of heartworm disease in
heartworm-endemic areas, administration of the drug should start at the
beginning of mosquito activity and be continued daily throughout the
mosquito season and for approximately a month thereafter. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[46 FR 23230, Apr. 24, 1981, as amended at 46 FR 41038, Aug. 14, 1981;
46 FR 46315, Sept. 18, 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805,
Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR 41489, Oct. 11, 1985; 50
FR 49372, Dec. 2, 1985; 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct.
18, 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, July 3, 1996; 62 FR
35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31,
2003]
[[Page 127]]
Sec. 520.622b Diethylcarbamazine citrate syrup.
(a)(1) Specifications. Each milliliter of syrup contains 60
milligrams of diethylcarbamazine citrate.
(2) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) The drug is indicated for use in dogs for
the prevention of infection with Dirofilaria immitis and T. canis and T.
leonina. It is also indicated for treatment of ascarid infections of T.
canis and T. leonina in dogs and T. cati in cats.
(ii) For prevention of heartworm and ascarid infections in dogs, the
drug may be added to the daily diet at a dosage rate of 3.0 milligrams
per pound of body weight per day or given directly by mouth at the same
dosage rate. For treatment of ascarid infections in dogs and cats, the
drug is administered at a dosage level of 25 to 50 milligrams per pound
of body weight preferably administered immediately after feeding.
(iii) Older dogs should be proven negative for the presence of
Dirofilaria immitis infection before administration of the drug. Those
with proven infection of Dirofilaria immitis should be rendered negative
using adulticidal and microfilaricidal drugs before administration of
this drug.
(iv) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(b)(1) Specifications. Each milliliter of syrup contains 60
milligrams of diethylcarbamazine citrate.
(2) Sponsors. (i) See No. 017030 for use as in paragraphs
(b)(3)(ii)(a) and (b)(3)(ii)(c) of this section.
(ii) See No. 017030 for use as in paragraphs (b)(3)(ii) (a) and (c)
of this section.
(3) Conditions of use--(i) Amount. 3 milligrams per pound of body
weight per day for prevention of heartworm disease and as an aid in
control of large roundworms; 25 to 50 milligrams per pound of body
weight as an aid in treatment of ascarid infections.
(ii) Indications for use. (a) For prevention of heartworm disease
(Dirofilaria immitis) in dogs.
(b) As an aid in control of large roundworms (T. canis) in dogs.
(c) As an aid in treatment of ascarid infections in dogs (T. canis)
and cats (T. canis and T. leonina).
(iii) Limitations. The drug may be placed on the daily ration or
given directly by mouth. For treatment of ascarid infections, a repeat
dose should be given in 10 to 20 days to remove immature worms which may
enter the intestine from the lungs after the first dose. Older dogs
should be proven negative for presence of Dirofilaria immitis infections
before administering the drug. Dogs with established heartworm
infections should not receive the drug until they have been converted to
a negative status by the use of adulticidal and microfilaricidal drugs.
Inadvertent administration to heartworm-infected dogs may cause adverse
reactions due to pulmonary occlusion. Overdosage may cause emesis. For
prevention of heartworm disease in heartworm-endemic areas,
administration of the drug should start 1 month before the mosquito
season and be continued daily throughout the mosquito season and for 2
months thereafter. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
(c)(1) Specifications. Each milliliter of syrup contains 60
milligrams of diethylcarbamazine citrate.
(2) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. (i) The drug is used in dogs between 4 weeks
and 8 months of age for the removal of ascarids (Toxacara canis) and in
animals over 4 weeks of age for the prevention of heartworm disease
(Dirofilaria immitis).
(ii) The drug is administered (a) for removal of ascarids at a
dosage of 50 milligrams per pound of body weight divided into two equal
doses and administered 8 to 12 hours apart (morning and night), orally
or mixed with either dry or wet food, and (b) for prevention of
heartworm disease at a dosage of 3 milligrams per pound of body weight
daily, orally or in food, in heartworm endemic areas, from the beginning
of mosquito activity, during the mosquito season, and for 2 months
following the end thereof.
(iii) Dogs older than 8 months of age may be infected with
Dirofilaria immitis.
[[Page 128]]
Use of the drug is contraindicated in dogs with active D. immitis
infections.
(iv) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 28265, July 9, 1976; 44
FR 3967, Jan. 19, 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, Aug. 13,
1982; 49 FR 33997, Aug. 28, 1984; 50 FR 41489, Oct. 11, 1985; 53 FR
47027, Oct. 18, 1988; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30,
1997; 62 FR 38906, July 21, 1997]
Sec. 520.622c Diethylcarbamazine citrate chewable tablets.
(a) Specifications. Each chewable tablet contains 30, 45, 60, 120,
150, or 180 milligrams of diethylcarbamazine citrate.
(b) Sponsors. See drug listing nos. in Sec. 510.600(c) of this
chapter for identification of sponsors as follows:
(1) For 015579, use of 30 or 120 milligram tablets as in paragraph
(c)(2)(i) of this section.
(2) For 000069, use of 60, 120, or 180 milligram tablets as in
paragraph (c)(2)(ii) of this section.
(3) For 061690, use of 45 or 150 milligram tablets as in paragraph
(c)(2)(iii) of this section.
(4) For 061133, use of 60-, 120-, or 180-milligram tablets as in
paragraph (c)(2)(i) of this section.
(5) For 000061, use of 60-milligram tablets as in paragraph
(c)(2)(i) of this section.
(6) For 000010, use of 30, 60, 120, or 180 milligram tablets as in
paragraph (c)(2)(i) of this section.
(7) [Reserved]
(c) Conditions of use--(1) Amount. 3 milligrams per pound of body
weight per day for prevention of heartworm disease and control of
ascarids; 25 to 50 milligrams per pound of body weight as an aid in
treatment of ascarid infections.
(2) Indications for use. (i) For prevention of heartworm disease
(Dirofilaria immitis) in dogs; as an aid in control of ascarids
(Toxocara canis) in dogs; as an aid in treatment of ascarid (Toxocara
canis and Toxascaris leonina) infections in dogs and cats.
(ii) For prevention of infection with Dirofilaria immitis (heartworm
disease) in dogs; as an aid in treatment of ascarid (Toxocara canis and
Toxascaris leonina) infections in dogs.
(iii) For prevention of heartworm disease (Dirofilaria immitis) in
dogs.
(3) Limitations. Tablets are administered orally or pulverized and
given in the feed. For treatment of ascarid infections, a repeat dose
should be given in 10 to 20 days to remove immature worms which may
enter the intestine from the lungs after the first dose. Dogs with
established heartworm infections should not receive the drug until they
have been converted to a negative status by the use of adulticidal and
microfilaricidal drugs. Inadvertent administration to heartworm-infected
dogs may cause adverse reactions due to pulmonary occlusion. Overdosage
may cause emesis. For prevention of heartworm disease in heartworm-
endemic areas, administration of the drug should start at the beginning
of mosquito activity and be continued daily throughout the mosquito
season and for approximately a month thereafter. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
[43 FR 6941, Feb. 17, 1978]
Editorial Note: For Federal Register citations affecting Sec.
520.622c, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.
Sec. 520.622d Diethylcarbamazine citrate capsules.
(a)(1) Specifications. Each capsule contains either 12.5, 50, 200,
or 400 milligrams of diethylcarbamazine citrate.
(2) Sponsor. See 011014 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount/indications for use. 3 milligrams
per pound of body weight daily for prevention of heartworm disease
(Dirofilaria immitis) in dogs; 25 to 50 milligrams per pound of body
weight in a single dose as an aid in the treatment of ascarid infections
in dogs (Toxocara canis and Toxascaris leonina).
(ii) Limitations. Administer orally directly or added to the daily
ration. For ascarid infections, repeat treatment in 10 to 20 days to
remove immature worms that may enter the intestine from the lungs after
the first dose. Do not treat dogs with established heartworm infections
until they have been converted to a negative status by the
[[Page 129]]
use of adulticidal and microfilaricidal drugs. Inadvertent
administration to heartworm-infected dogs may cause adverse reactions
due to pulmonary occlusion or shock. Overdosage may cause emesis. For
prevention of heartworm disease in heartworm-endemic areas,
administration of the drug should begin 1 month before and continue 2
months after the mosquito season. Dogs receiving prophylactic therapy
should be examined every 6 months for the presence of microfilariae.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(b)(1) Specifications. Each capsule contains either 12.5, 50, 200,
or 400 milligrams of diethylcarbamazine citrate.
(2) Sponsor. See 023851 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount/indications for use. 3 milligrams
per pound of body weight daily for prevention of heartworm disease
(Dirofilaria immitis) in dogs.
(ii) Limitations. Capsules may be administered to the dog directly
or added to the daily ration. For oral administration only. Do not treat
dogs with established heartworm infections until they have been
converted to a negative status by the use of adulticidal and
microfilaricidal drugs. Inadvertent administration to heartworm infected
dogs may cause adverse reactions due to pulmonary occlusion or shock.
For prevention of heartworm disease in heartworm-endemic areas,
administration of the drug should begin 1 month before and continue 2
months after the mosquito season. Dogs receiving prophylactic therapy
should be examined every 6 months for the presence of microfilariae.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
[47 FR 26377, June 18, 1982, as amended at 48 FR 46979, Oct. 17, 1983;
49 FR 5099, Feb. 10, 1984]
Sec. 520.623 Diethylcarbamazine citrate, oxibendazole chewable tablets.
(a) Specifications. Each tablet contains either 60, 120, or 180
milligrams of diethylcarbamazine citrate with 45, 91, or 136 milligrams
of oxibendazole, respectively.
(b) Sponsor. See 000069 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer orally to dogs
at a dosage level of 6.6 milligrams of diethylcarbamazine citrate per
kilogram of body weight (3 milligrams per pound of body weight) and 5.0
milligrams of oxibendazole per kilogram of body weight (2.27 milligrams
per pound of body weight).
(2) Indications for use. For prevention of infection with
Dirofilaria immitis (heartworm disease) and Ancylostoma caninum
(hookworm infection) and for removal and control of Trichuris vulpis
(whipworm infection) and mature and immature stages of intestinal
Toxocara canis (ascarid infection).
(3) Limitations. Orally administer daily during heartworm season.
For free-choice feeding or broken and placed on or mixed with feed. Do
not use in dogs that may harbor adult heartworms. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
[50 FR 28768, July 16, 1985, as amended at 53 FR 45759, Nov. 14, 1988;
54 FR 3776, Jan. 26, 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, Oct.
8, 1991; 60 FR 55659, Nov. 2, 1995]
Sec. 520.645 Difloxacin.
(a) Specifications. Each tablet contains 11.4, 45.4, or 136
milligrams (mg) of difloxacin hydrochloride.
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use--(1) Dogs--(i) Amount. 5 to 10 mg per kilogram
(2.3 to 4.6 mg/pound) of body weight.
(ii) Indications for use. For management of diseases in dogs
associated with bacteria susceptible to difloxacin.
(iii) Limitations. Use once a day for 2 to 3 days beyond cessation
of clinical signs of disease up to a maximum of 30 days. Federal law
prohibits the extra-label use of this drug in food-producing animals.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) [Reserved]
[63 FR 8123, Feb. 18, 1998]
[[Page 130]]
Sec. 520.763 Dithiazanine iodide oral dosage forms.
Sec. 520.763a Dithiazanine iodide tablets.
(a) Chemical name. 3-Ethyl-2-[5-(3-ethyl - 2 -
benzothiazolinylidene) - 1,3 - pentadienyl]-benzothiazolium iodide.
(b) Specifications. Dithiazanine iodide tablets contain 10
milligrams, 50 milligrams, 100 milligrams, or 200 milligrams of
dithiazanine iodide in each tablet.
(c) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) The tablets are administered orally to
dogs immediately after feeding using the following dosage schedule for
various parasite infestations:
------------------------------------------------------------------------
Milligrams
per pound Length of
of body treatment--days
weight
------------------------------------------------------------------------
Large roundworms (Toxocara canis, 10 3-5
Toxascaris leonina).......................
Hookworms (Ancylostoma caninum, Uncinaria 10 7
stenocephala).............................
Whipworms (Trichuris vulpis)............... 10
Strongyloides (Strongyloides canis, 10 10-12
Strongyloides stercoralis)................
Heartworm microfilariae (Dirofilaria 3-5 7-10
immitus)..................................
------------------------------------------------------------------------
Note: Treatment with dithiazanine iodide for heartworm microfilariae
should follow 6 weeks after therapy for adult worms.
(2) The drug is contraindicated in animals sensitive to dithiazanine
iodide and should be used cautiously, if at all, in dogs with reduced
renal function.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(e) Use for treating dogs for large roundworms, hookworms,
whipworms, and strongyloides as provided for in this section has been
NAS/NRC reviewed and deemed effective. Applications for these uses need
not include effectiveness data as specified by Sec. 514.111 of this
chapter, but may require bioequivalency and safety information.
[40 FR 13838, Mar. 27, 1975, as amended at 47 FR 51564, Nov. 16, 1982;
48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076,
June 30, 1997]
Sec. 520.763b Dithiazanine iodide powder.
(a) Chemical name. 3-Ethyl-2-[5-(3-ethyl-2-benzothiazolinylidene)-
1,3-pentadienyl]-benzothiazoliumiodide.
(b) Specifications. Dithiazanine iodide powder contains 200
milligrams of dithiazanine iodide per level standard tablespoon.
(c) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(d) Conditions of use. (1) Dithiazanine iodide powder is
administered to dogs by mixing the proper dosage in the dog's food,
using the following dosage schedule for various parasite infestations:
------------------------------------------------------------------------
Milligrams
per pound Length of
of body treatment--days
weight
------------------------------------------------------------------------
Large roundworms (Toxocara canis, 10 3-5
Toxascaris leonina).......................
Hookworms (Ancylostoma caninum, Uncinaria 10 7
stenocephala).............................
Whipworms (Trichuris vulpis)............... 10 7
Strongyloides (Strongyloides canis, 10 10-12
Strongyloides stercoralis)................
Heartworm microfilariae (Dirofilaria 3-5 7-10
immitus)..................................
------------------------------------------------------------------------
Note: Treatment with dithiazanine iodide for heartworm microfilariae
should follow 6 weeks after therapy for adult worms.
(2) The drug is contraindicated in animals sensitive to dithiazanine
iodide and should be used cautiously, if at all, in dogs with reduced
renal function.
(3) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(e) Use for treating dogs for large roundworms, hookworms,
whipworms, and strongyloides as provided for in this section has been
NAS/NRC reviewed and deemed effective. Applications for these uses need
not include effectiveness data as specified by Sec. 514.111 of this
chapter, but may require bioequivalency and safety information.
[40 FR 13838, Mar. 27, 1975, as amended at 47 FR 51564, Nov. 16, 1982;
48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076,
June 30, 1997]
Sec. 520.763c Dithiazanine iodide and piperazine citrate suspension.
(a) Specifications. Each milliliter of the drug contains 69
milligrams of dithiazanine iodide and 83 milligrams
[[Page 131]]
of piperazine base (as piperazine citrate).
(b) Sponsor. See 000010 in Sec. 510.600(c) of this chapter.
(c) NAS/NRC status. The conditions of use are NAS/NRC reviewed and
found effective. Applications for these uses need not include
effectiveness data as specified by Sec. 514.111 of this chapter, but
may require bioequivalency and safety information.
(d) Conditions of use--(1) Amount. 1 ounce (30 milliliters) per 100
pounds of body weight for the first 500 pounds; \3/4\ ounce for each 100
pounds thereafter, up to 1,200 pounds; 10\1/4\ ounces to animals over
1,200 pounds.
(2) Indications for use. For control of large roundworms, Parascaris
equorum; small strongyles; large strongyles, Strongylus vulgaris; and
pinworms, Oxyuris equi.
(3) Limitations. Administer by drench or mixed with the daily ration
as a single dose. Treatment is recommended in spring and fall. In a
heavily infested environment, treatment may be repeated every 30 days.
Not for use in horses intended for food purposes. Severely debilitated
animals should not be wormed except on the advice of a veterinarian. If
the drug is for administration by stomach tube, it shall be labeled:
``Federal law restricts this drug to use by or on the order of a
licensed veterinarian.''
[47 FR 52696, Nov. 23, 1982, as amended at 48 FR 32342, July 15, 1983;
53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997]
Sec. 520.784 Doxylamine succinate tablets.
(a) Specifications. The drug is in tablet form and contains
doxylamine succinate as the active drug ingredient.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is used in conditions in which
antihistaminic therapy may be expected to alleviate some signs of
disease in horses, dogs, and cats. \1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter.
---------------------------------------------------------------------------
(2) It is administered orally to horses at a dosage level of 1 to 2
milligrams per pound of body weight per day divided into 3 or 4 equal
doses. It is administered orally to dogs and cats at a dosage level of 2
to 3 milligrams per pound of body weight per day divided into 3 or 4
equal doses. \1\
(3) Not for use in horses intended for food. \1\
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian. \1\
[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 60140, Nov. 25, 1977;
46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov.
19, 1997]
Sec. 520.804 Enalapril tablets.
(a) Specifications. Each tablet contains either 1.0, 2.5, 5.0, 10.0,
or 20.0 milligrams of enalapril maleate.
(b) Sponsor. See 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. 0.5 to 1.0 milligram of
enalapril maleate per kilogram of body weight per day.
(ii) Indications for use. Treatment of mild, moderate, and severe
(modified New York Heart Association Class II, III, IV) heart failure in
dogs.
(iii) Limitations. Use 0.5 milligram per kilogram once daily. In the
absence of adequate clinical response within a 2-week period, use may be
increased to twice daily (a total of 1.0 milligram per kilogram).
Enalapril maleate is administered as conjunctive therapy with furosemide
and digoxin in the treatment of dilated cardiomyopathy and furosemide
with or without digoxin in the treatment of chronic valvular disease.
The safety of enalapril for use in breeding dogs has not been
established. Use in pregnant bitches is not recommended. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(2) [Reserved]
[59 FR 17694, Apr. 14, 1994, as amended at 62 FR 63270, Nov. 28, 1997]
Sec. 520.812 Enrofloxacin tablets.
(a) Specifications. Each tablet contains either 22.7, 68.0, or 136.0
milligrams of enrofloxacin.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
[[Page 132]]
(d) Conditions of use--(1) Amount. 5 to 20 milligrams per kilogram
(2.27 to 9.07 milligrams per pound) of body weight.
(2) Indications for use. Dogs and cats for management of diseases
associated with bacteria susceptible to enrofloxacin.
(3) Limitations. Administer orally as a single dose or divided into
2 equal doses at 12 hour intervals, daily. Administer for at least 2 to
3 days beyond cessation of clinical symptoms, for a maximum of 30 days.
Safety in breeding or pregnant cats has not been established. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
[54 FR 3444, Jan. 24, 1989, as amended at 55 FR 43327, Oct. 29, 1990; 62
FR 38906, July 21, 1997; 64 FR 48295, Sept. 3, 1999]
Sec. 520.813 Enrofloxacin oral solution.
(a) Specifications. Each milliliter of concentrate solution contains
32.3 milligrams of enrofloxacin.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.228 of this chapter.
(d) Conditions of use. It is used in drinking water as follows:
(1) Chickens and turkeys--(i) Amount. 25 to 50 parts per million of
enrofloxacin in drinking water.
(ii) Indications. Chickens: Control of mortality associated with
Escherichia coli susceptible to enrofloxacin. Turkeys: Control of
mortality associated with E. coli and Pasteurella multocida (fowl
cholera) susceptible to enrofloxacin.
(iii) Limitations. Do not use in laying hens producing eggs for
human consumption. Administer medicated water continuously as sole
source of drinking water for 3 to 7 days. Prepare fresh stock solution
daily. Effects on the reproductive function of turkeys have not been
determined. Treated animals must not be slaughtered for food within 2
days of the last treatment. Individuals with a history of
hypersensitivity to quinolones should avoid exposure to this product.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) [Reserved]
[61 FR 56893, Nov. 5, 1996]
Sec. 520.816 Epsiprantel tablets.
(a) Specifications. Each tablet contains either 12.5, 25, 50, or 100
milligrams of epsiprantel.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. 2.5 milligrams per
pound of body weight.
(ii) Indications for use. Removal of canine cestodes Dipylidium
caninum and Taenia pisiformis.
(2) Cats--(i) Amount. 1.25 milligrams per pound of body weight.
(ii) Indications for use. Removal of feline cestodes D. caninum and
T. taeniaeformis.
(3) Limitations. For oral use only as a single dose. Do not use in
animals less than 7 weeks of age. Safety of use in pregnant or breeding
animals has not been established. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
[54 FR 50615, Dec. 8, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60
FR 55659, Nov. 2, 1995]
Sec. 520.823 Erythromycin phosphate.
(a) Specifications. Erythromycin phosphate is the phosphate salt of
the antibiotic substance produced by the growth of Streptomyces
erythreus or the same antibiotic substance produced by any other means.
One gram of erythromycin phosphate is equivalent to 0.89 gram of
erythromycin master standard.
(b) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.230 of this chapter.
(d) Conditions of use. It is used in drinking water as follows:
(1) Broiler and replacement chickens--(i) Amount. 0.500 gram per
gallon.
(ii) Indications for use. As an aid in the control of chronic
respiratory disease due to Mycoplasma gallisepticum susceptible to
erythromycin.
(iii) Limitations. Administer for 5 days; do not use in replacement
pullets over 16 weeks of age; do not use in chickens producing eggs for
human consumption; to assure effectiveness, treated birds must consume
enough medicated water to provide a therapeutic dosage; solutions older
than 3
[[Page 133]]
days should not be used; withdraw 1 day before slaughter.
(2) Replacement chickens and chicken breeders--(i) Amount. 0.500
gram per gallon.
(ii) Indications for use. As an aid in the control of infectious
coryza due to Hemophilus gallinarum susceptible to erythromycin.
(iii) Limitations. Administer for 7 days; do not use in replacement
pullets over 16 weeks of age; do not use in chickens producing eggs for
human consumption; to assure effectiveness, treated birds must consume
enough medicated water to provide a therapeutic dosage; solutions older
than 3 days should not be used; withdraw 1 day before slaughter.
(3) Growing turkeys--(i) Amount. 0.500 gram per gallon.
(ii) Indications for use. As an aid in the control of blue comb
(nonspecific infectious enteritis) caused by organisms susceptible to
erythromycin.
(iii) Limitations. Administer for 7 days; do not use in turkeys
producing eggs for human consumption; to assure effectiveness, treated
birds must consume enough medicated water to provide a therapeutic
dosage; solutions older than 3 days should not be used; withdraw 1 day
before slaughter.
[40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980;
66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003]
Sec. 520.863 Ethylisobutrazine hydrochloride tablets.
(a) Specifications. Each tablet contains either 10 milligrams or 50
milligrams of ethylisobutrazine hydrochloride.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) It is administered orally to dogs as a
tranquilizer.\1\
---------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and deemed effective.
Applications for these uses need not include effectiveness data as
specified by Sec. 514.111 of this chapter, but may require
bioequivalency and safety information.
---------------------------------------------------------------------------
(2) It is administered once daily at a dosage level of 2 to 5
milligrams of ethylisobutrazine hydrochloride per pound of body
weight.\1\
(3) It is not to be used in conjunction with organophosphates and/or
procaine hydrochloride because phenothiazine may potentiate the toxicity
of organophosphates and the activity of procaine hydrochloride.\1\
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.\1\
[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61
FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]
Sec. 520.870 Etodolac.
(a) Specifications. Each tablet contains 150, 300, or 500 milligrams
(mg) of etodolac.
(b) Sponsor. See 053501 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use--(1) Dogs--(i) Amount. 10 to 15 mg per
kilogram (4.5 to 6.8 mg/pound) of body weight per day.
(ii) Indications for use. For the management of pain and
inflammation associated with osteoarthritis in dogs.
(iii) Limitations. Use once-a-day. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
(2) [Reserved]
[63 FR 51300, Sept. 25, 1998, as amended at 68 FR 51705, Aug. 28, 2003]
Sec. 520.903 Febantel oral dosage forms.
Sec. 520.903a Febantel paste.
(a) Chemical name. Dimethyl [[2-[(methoxyacetyl)amino]-4-(phenyl-
thio)phenyl] carbonimidoyl]bis [carbamate].
(b) Specifications. The drug is a paste containing 45.5 percent
febantel.
(c) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(d) Conditions of use--(1) Amount. Six milligrams per kilogram (2.73
milligrams per pound) of body weight in horses.
(2) Indications for use. For removal of large strongyles (Strongylus
vulgaris, S. edentatus, S. equinus); ascarids (Parascaris equorum--
sexually mature and immature); pinworms (Oxyuris equi-- adult and 4th
stage larva); and the various small strongyles in horses, foals, and
ponies.
(3) Limitations. (i) The paste may be administered on the base of
the tongue or well mixed into a portion of the normal grain ration.
[[Page 134]]
(ii) [Reserved]
(iii) For animals maintained on premises where reinfection is likely
to occur, retreatment may be necessary. For most effective results,
retreat in 6 to 8 weeks.
(iv) Not for use in horses intended for food.
(v) Consult your veterinarian for assistance in the diagnosis,
treatment, and control of parasitism.
[43 FR 8797, Mar. 3, 1978; 43 FR 12311, Mar. 24, 1978, as amended at 43
FR 60882, Dec. 29, 1978. Redesignated at 45 FR 8587, Feb. 8, 1980]
Sec. 520.903b Febantel suspension.
(a) Specifications. The suspension contains 9.3 percent (2.75 grams
per ounce) febantel.
(b) Sponsor. See 000859 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. 3 milliliters per 100 pounds body
weight or 1 fluid ounce per 1000 pounds (6 milligrams per kilogram body
weight).
(2) Indications for use. For removal of ascarids (Parascaris
equorum--adult and sexually immature), pinworms (Oxyuris equi--adult and
4th stage larvae), large strongyles (Strongylus vulgaris, S. edentatus,
S. equinus), and the various small strongyles in horses, breeding
stallions and mares, pregnant mares, foals, and ponies.
(3) Limitations. Administer by stomach tube or drench, or by mixing
well into a portion of the normal grain ration. For animals maintained
on premises where reinfection is likely to occur, retreatment may be
necessary. For most effective results, retreat in 6 to 8 weeks. Not for
use in horses intended for food. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(d) Special considerations. Febantel suspension may be used in
combination with trichlorfon oral liquid in accordance with the
provisions of Sec. 520.2520c, this section, and the following
conditions:
(1) Combine 1 part febantel suspension with 5 parts trichlorfon
liquid.
(2) Allow animal to consume a portion of daily grain ration;
administer mixture by stomach tube at rate of 18 milliliters per 100
pounds of body weight.
[45 FR 8587, Feb. 8, 1980]
Sec. 520.903c [Reserved]
Sec. 520.903d Febantel-praziquantel paste.
(a) Specifications. Each gram of paste contains 34 milligrams of
febantel and 3.4 milligrams of praziquantel.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount--(i) Dogs and cats (over 6 months
of age): 10 milligrams of febantel and 1 milligram of praziquantel per
kilogram of body weight (1 gram of paste per 7.5 pounds body weight)
administered by mouth or in the food once daily for 3 days.
(ii) Puppies and kittens (less than 6 months of age): 15 milligrams
of febantel and 1.5 milligrams of praziquantel per kilogram of body
weight (1 gram of paste per 5 pounds body weight) administered by mouth
on a full stomach once daily for 3 days.
(2) Indications for use. (i) Dogs and puppies: For removal of
hookworms (Ancylostoma caninum and Uncinaria stenocephala), whipworms
(Trichuris vulpis), ascarids (Toxocara canis and Toxascaris leonina),
and tapeworms (Dipylidium caninum and Taenia pisiformis).
(ii) Cats and kittens: For removal of hookworms (Ancylostoma
tubaeforme), ascarids (Toxocara cati) and tapeworms (Dipylidium caninum
and Taenia taeniaeformis).
(3) Limitations. Do not use in pregnant animals. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(4) Special considerations. Consider alternative therapy or use with
caution in animals with pre-existing liver or kidney dysfunction.
[50 FR 19167, May 7, 1985, as amended at 53 FR 48533, Dec. 1, 1988; 56
FR 50813, Oct. 9, 1991]
Sec. 520.903e Febantel tablets.
(a) Specifications. Each scored tablet contains 27.2 milligrams of
febantel for use in dogs, puppies, cats, and kittens or 163.3 milligrams
of febantel for use in dogs, puppies, and cats.
(b) Sponsor. See 000859 in Sec. 510.600(c)(2) of this chapter.
[[Page 135]]
(c) Conditions of use--(1) Amount--(i) Dogs and cats. Ten milligrams
per kilogram body weight. Administer once daily for 3 consecutive days.
(ii) Puppies and kittens fewer than 6 months of age. Fifteen
milligrams per kilogram body weight. Administer once daily for 3
consecutive days.
(2) Indications for use. (i) For removal of hookworms (Ancylostoma
caninum and Uncinaria stenocephala), ascarids (Toxocara canis and
Toxascaris leonina) and whipworms (Trichuris vulpis) in dogs and
puppies.
(ii) For removal of hookworms (Ancylostoma tubaeforme) and ascarids
(Toxocara cati) in cats and kittens.
(3) Limitations. Do not use in pregnant animals. Consider
alternative therapy or use with caution in animals with preexisting
liver or kidney dysfunction. Administer to puppies and kittens on a full
stomach. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
[56 FR 50655, Oct. 8, 1991]
Sec. 520.905 Fenbendazole oral dosage forms.
Sec. 520.905a Fenbendazole suspension.
(a) Specifications. The drug is a suspension containing 10 percent
(100 milligrams per milliliter) fenbendazole.
(b) Sponsor. See No. 057926 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.275 of this chapter.
(d) Conditions of use--(1) Horses--(i) Amount. 5 milligrams per
kilogram (2.3 milligrams per pound) for the control of large strongyles,
small strongyles, and pinworms; 10 milligrams per kilogram for the
control of ascarids.
(ii) Indications for use. For the control of large strongyles
(Strongylus edentatus, S. equinus, S. vulgaris), small strongyles
(Cyanthostomum spp., Cylicocyclus spp., Cylicostephanus spp.,
Triodontophorus spp.), pinworms (Oxyuris equi), and ascarids (Parascaris
equorum) in horses.
(iii) Limitations. Administer orally by dose syringe or suitable
plastic syringe. Do not use in horses intended for food. Consult a
veterinarian for assistance in the diagnosis, treatment, and control of
parasitism.
(2) Cattle including dairy cows of breeding age--(i) Amount.
Administer orally 5 milligrams per kilogram of body weight (2.3
milligrams per pound).
(ii) Indications for use. For the removal and control of lungworm
(Dictyocaulus viviparus); stomach worm (adults)--brown stomach worm
(Ostertagia ostertagi); stomach worms (adults and 4th-stage larvae)--
barberpole worm (Haemonchus contortus and H. placei) and small stomach
worm (Trichostongylus axei); intestinal worms (adults and 4th-stage
larvae)--hookworm (Bunostonmum phlebotomum), threadnecked intestinal
worm (Nematodirus helvetianus), small intestinal worm (Cooperia punctata
and C. oncophora), bankrupt worm (Trichostrongylus colubriformis), and
nodular worm (Oesophagostomum radiatum).
(iii) Limitations. Retreatment may be needed after 4 to 6 weeks.
Cattle must not be slaughtered within 8 days following last treatment.
Consult a veterinarian for assistance in the diagnosis, treatment, and
control of parasitism.
(3) Beef cattle--(i) Amount. Administer orally 10 milligrams per
kilogram of body weight.
(ii) For the removal and control of stomach worm (4th-stage
inhibited larvae/type II ostertagiasis), Ostertagia ostertagi, and
tapeworm, Moniezia benedeni.
(iii) Limitations. Retreatment may be needed after 4 to 6 weeks.
Cattle must not be slaughtered within 8 days following last treatment.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(4) Goats--(i) Amount. Administer orally 5 milligrams per kilogram
of body weight (2.3 milligrams per pound).
(ii) Indications for use. For the removal and control of stomach
worms (adults) Haemonchus contortus and Teladorsagia circumcincta.
(iii) Limitations. Retreatment may be needed after 4 to 6 weeks.
Goats must not be slaughtered for food within 6 days following last
treatment. Do not use in lactating goats.
(e) Special considerations. Fenbendazole suspension 10 percent and
approved forms of trichlorfon, when used concomitantly for treating
[[Page 136]]
the indications provided in paragraph (d) of this section and for
treating infections of stomach bot as provided in Sec. 520.2520, have
been shown to be compatible and not to interfere with one another.
[42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. 24, 1978. Redesignated at
44 FR 1375, Jan. 5, 1979, and amended at 46 FR 29464, June 2, 1981; 47
FR 15327, Apr. 9, 1982; 48 FR 42809, Sept. 20, 1983; 49 FR 1983, Jan.
17, 1984; 53 FR 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; 61 FR
29478, June 11, 1996; 63 FR 63983, Nov. 18, 1998; 66 FR 47960, Sept. 17,
2001; 68 FR 26205, May 15, 2003]
Sec. 520.905b Fenbendazole granules.
(a) Specifications. Each gram of granules contains 222 milligrams
(mg) fenbendazole.
(b) Sponsor. See No. 057926 in Sec. 510.600(c) of this chapter.
(c) Special considerations. See Sec. 500.25 of this chapter.
(d) Conditions of use--(1) Horses--(i) Amount. 5 mg/kilogram (kg)
for large strongyles, small strongyles, and pinworms; 10 mg/kg for
ascarids.
(ii) Indications for use. For the control of infections of large
strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small
strongyles, pinworms (Oxyuris equi), and ascarids (Parascaris equorum).
(iii) Limitations. Sprinkle the appropriate amount of drug on a
small amount of the usual grain ration. Prepare for each horse
individually. Withholding feed or water is not necessary. Retreat in 6
to 8 weeks if required. Do not use in horses intended for food.
(2) Dogs--(i) Amount. 50 mg/kg daily for 3 consecutive days.
(ii) Indications for use. For the removal of ascarids (Toxocara
canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria
stenocephala), whipworms (Trichuris vulpis), and tapeworms (Taenia
pisiformis).
(iii) Limitations. Mix the appropriate amount of drug with a small
amount of the usual food; dry dog food may require slight moistening to
facilitate mixing. Medicated food must be fully consumed.
(3) Zoo and wildlife animals--(i) Amount. 10 mg/kg per day for 3
days.
(ii) Indications for use. For control of internal parasites of
Felidae and Ursidae as follows:
(A) Lion (Panthera leo) and Tiger (Panthera tigris): Ascarid
(Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma spp.).
(B) Cheetah (Acinonyx jubatus): Ascarid (Toxocara cati, Toxascaris
leonina).
(C) Puma (Felis concolor), Panther (Panthera spp.), Leopard
(Panthera pardus), Jaguar (Panthera onca): Ascarid (Toxocara cati,
Toxascaris leonina), Hookworm (Ancylostoma spp.), Tapeworm (Taenia
hydatigena, T. krabbei, T. taeniaeformis).
(D) Black Bear (Ursus americanus): Ascarid (Baylisascaris transfuga,
Toxascaris leonina), Hookworm (Ancylostoma caninum), Tapeworm (Taenia
hydatigena, T. krabbei).
(E) Polar Bear (Ursus maritimus) and Grizzly Bear (Ursus
horribilis): Ascarid (Baylisascaris transfuga, Toxascaris leonina).
(iii) Limitations. Top dress or mix with a small portion of food.
Must be fully consumed prior to feeding. Federal law restricts this drug
to use by or on the order of a licensed veterinarian. Do not use 14 days
before or during the hunting season.
[44 FR 1375, Jan. 5, 1979, as amended at 47 FR 15327, Apr. 9, 1982; 48
FR 50528, Nov. 2, 1983; 59 FR 35252, July 11, 1994; 66 FR 47960, Sept.
17, 2001; 67 FR 47450, July 19, 2002]
Sec. 520.905c Fenbendazole paste.
(a) Specifications. The product is an aqueous paste containing 10
percent fenbendazole.
(b) Sponsor. See No. 057926 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.275 of this chapter.
(d) Conditions of use--(1) Horses--(i)(a) Amount. 2.3 milligrams per
pound of body weight (one 2.5-gram fenbendazole syringe for a 1,100-
pound horse). For foals and weanlings (less than 18 months of age), 4.6
milligrams per pound of body weight (one 2.5-gram fenbendazole syringe
for each 550 pounds of body weight).
(b) Indications for use. For control of large strongyles (Strongylus
edentatus, S. equinus, S. vulgaris), small strongyles, pinworms (Oxyuris
equi),
[[Page 137]]
and ascarids (Parascaris equorum) in horses.
(c) Limitations. Retreatment at intervals of 6 to 8 weeks may be
required. Do not use in horses intended for food. Consult your
veterinarian for assistance in the diagnosis, treatment, and control of
parasitism.
(ii)(a) Amount. 4.6 milligrams per pound of body weight (one 2.5-
gram fenbendazole syringe for a 550-pound horse) daily for 5 days.
(b) Indications for use. For control of arteritis caused by the
fourth stage larvae of Strongylus vulgaris.
(c) Limitations. Treatment should be initiated in the spring and
repeated in 6 months. Do not use in horses intended for food. Consult
your veterinarian for assistance in the diagnosis, treatment, and
control of fourth stage larvae of S. vulgaris.
(iii)(a) Amount. 4.6 milligrams per pound of body weight (10
milligrams per kilogram) daily for 5 consecutive days.
(b) Indications for use. For treatment of encysted mucosal
cyathostome (small strongyle) larvae including early third stage
(hypobiotic), late third stage, and fourth stage larvae in horses.
(c) Limitations. (Consult your veterinarian for assistance in the
diagnosis, treatment, and control of encysted mucosal cyathostomes). Do
not use in horses intended for food.
(2) Beef and dairy cattle--(i) Amount. Administer orally 5
milligrams per kilogram of body weight (2.3 milligrams per pound).
(ii) Indications for use. For the removal and control of lungworm
(Dictyocaulus viviparus), barberpole worm (Haemonchus contortus), brown
stomach worm (Ostertagia ostertagi), small stomach worm
(Trichostrongylus axei), hookworm (Bunostomum phlebotomum), thread-
necked intestinal worm (Nematodirus helvetianus), small intestinal worms
(Cooperia punctata and C. oncophora), bankrupt worm (Trichostrongylus
colubriformis), and nodular worm (Oesophagostomum radiatum).
(iii) Limitations. Re-treatment may be needed after 4 to 6 weeks.
Cattle must not be slaughtered within 8 days following last treatment.
Consult a veterinarian for assistance in the diagnosis, treatment, and
control of parasitism.
(e) Special considerations. Fenbendazole paste 10 percent may be
used concomitantly with approved forms of trichlorfon for the
indications provided in paragraph (d)(1)(i) of this section and for
treating infections of stomach bots as provided in Sec. 520.2520.
[46 FR 32018, June 19, 1981, as amended at 47 FR 15327, Apr. 9, 1982; 49
FR 8433, Mar. 7, 1984; 50 FR 26358, June 26, 1985; 61 FR 29478, June 11,
1996; 63 FR 31624, June 10, 1998; 66 FR 47960, Sept. 17, 2001]
Sec. 520.905d Fenbendazole powder.
(a) Specifications. (1) Each 2-ounce packet contains 2.27 grams (4
percent) of fenbendazole plus other inert ingredients.
(2) Each 4-ounce packet contains 1.7 grams (1.5 percent) of
fenbendazole plus other inert ingredients.
(b) Sponsors. (1) See No. 057926 in Sec. 510.600(c) of this chapter
for use of the 4-percent product.
(2) See No. 017800 in Sec. 510.600(c) of this chapter for use of
the 1.5-percent product.
(c) Related tolerances. See Sec. 556.275 of this chapter.
(d) Conditions of use. It is administered to swine as follows:
(1) Amount. 3 milligrams fenbendazole per kilogram body weight per
day (1.36 milligrams per pound per day).
(2) Indications for use. For removal and control of large roundworms
(Ascaris suum); lungworms (Metastrongylus apri); nodular worms
(Oesophagostomum dentatum, O. quadrispinulatum); small stomach worms
(Hyostrongylus rubidus); whipworms (Trichuris suis); and kidneyworms
(Stephanurus dentatus-- mature and immature).
(3) Limitations. Thoroughly mix the contents of the packet(s) with
swine ration and administer according to label directions. Feed as sole
ration for 3 consecutive days. Can be fed to pregnant sows. No prior
withdrawal of feed or water is necessary. Consult your
[[Page 138]]
veterinarian for assistance in the diagnosis, treatment, and control of
parasitism.
[49 FR 18090, Apr. 27, 1984, as amended at 49 FR 20485, May 15, 1984; 66
FR 47960, Sept. 17, 2001]
Sec. 520.905e Fenbendazole blocks.
(a) Specifications. (1) Each pound of molasses block contains 750
milligrams of fenbendazole.
(2) Each pound of protein block contains 750 milligrams of
fenbendazole.
(b) Sponsor. See 057926 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.275 of this chapter.
(d) Conditions of use--(1) Amount. 0.1 pound of block per 100 pounds
of body weight per day for 3 days. Total dose for the 3-day period is
2.27 milligrams of fenbendazole per pound of body weight for mature
cattle.
(2) Indications for use. For removal and control of infections of
lungworms (Dictyocaulus viviparus) and gastrointestinal roundworms
(Haemonchus contortus, Ostertagia ostertagi, Trichostrongylus axei,
Bunostomum phlebotomum, Nematodirus helvetianus, Cooperia oncophora and
C. punctata, Trichostrongylus colubriformis, and Oesophagostomum
radiatum) in beef cattle.
(3) Limitations. Administer free choice of beef cattle on pasture
that have become accustomed to nonmedicated block feeding during an
adaptation period of 12 to 19 days. Molasses block: Cattle must not be
slaughtered within 11 days following last treatment. Protein block:
Cattle must not be slaughtered within 16 days following last treatment;
do not use in dairy cattle of breeding age. Animals maintained under
conditions of constant worm exposure may require retreatment within 6 to
8 weeks. Consult your veterinarian for assistance in the diagnosis,
treatment, and control of parasitism.
[51 FR 41783, Nov. 19, 1986, as amended at 54 FR 20787, May 15, 1989; 66
FR 47960, Sept. 17, 2001]
Sec. 520.928 Firocoxib.
(a) Specifications. Each chewable tablet contains 57 or 227
milligrams (mg) firocoxib.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. 5 mg per kilogram (2.27
mg per pound) body weight once daily.
(2) Indications for use. For the control of pain and inflammation
associated with osteoarthritis.
(3) Limitations. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
[69 FR 51171, Aug. 18, 2004]
Sec. 520.955 Florfenicol.
(a) Specifications. Each milliliter (mL) contains 23 milligrams (mg)
florfenicol.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.283 of this chapter.
(d) Conditions of use in swine--(1) Amount. Administer in drinking
water ad libitum at 400 mg per gallon (100 parts per million (ppm)) for
5 consecutive days.
(2) Indications for use. For the treatment of swine respiratory
disease (SRD) associated with Actinobacillus pleuropneumoniae,
Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis
Type 2.
(3) Limitations. Do not slaughter within 16 days of last treatment.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
[67 FR 78357, Dec. 24, 2002]
Sec. 520.960 Flumethasone tablets.
(a) Specifications. Each tablet contains 0.0625 milligram of
flumethasone.
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. (i) Dogs: Administer orally from
0.0625 to 0.25 milligram daily in divided doses.
(ii) Cats: Administer orally from 0.03125 to 0.125 milligram daily
in divided doses.
(2) Indications for use. (i) Dogs: It is used for musculoskeletal
conditions due to inflammation of muscles or joints and accessory
structures, where permanent structural changes do not exist, such as
arthritis, the disc syndrome, and myositis.
[[Page 139]]
(ii) Dogs and cats: It is used in certain acute and chronic
dermatoses of varying etiology to help control the pruritus, irritation,
and inflammation associated with these conditions.
(3) Limitations. Do not use in viral infections. Anti-inflammatory
action of corticosteroids may mask signs of infection. Do not use in
animals with tuberculosis, chronic nephritis, cushingoid syndrome, or
where peptic ulcers occur, except for emergency therapy. Clinical and
experimental data have demonstrated that corticosteroids administered
orally or parenterally to animals may induce the first stage of
parturition when administered during last trimester of pregnancy and may
precipitate premature parturition followed by dystocia, fetal death,
retained placenta, and metritis. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
[44 FR 7131, Feb. 6, 1979, as amended at 61 FR 5506, Feb. 13, 1996]
Sec. 520.970 Flunixin oral dosage forms.